U.S. patent number 10,226,335 [Application Number 15/189,786] was granted by the patent office on 2019-03-12 for actively controllable heart valve implant and method of controlling same.
This patent grant is currently assigned to Edwards Lifesciences CardiAQ LLC. The grantee listed for this patent is Edwards Lifesciences CardiAQ, LLC. Invention is credited to Richard Cartledge, Derek Dee Deville, James L. Greene, Jorge Jimenez, Kevin W. Smith.
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United States Patent |
10,226,335 |
Cartledge , et al. |
March 12, 2019 |
Actively controllable heart valve implant and method of controlling
same
Abstract
A mitral valve implant includes a force-expanding mitral valve
lattice having an interior orifice and a self-expanding valve
trampoline attached at the interior orifice of the force-expanding
mitral valve lattice. The mitral valve lattice is self-expandable
to a first configuration and force expandable from the first
configuration to a second configuration. The configurations can be
circular or D-shaped. The mitral valve lattice comprises jack
screws adjusting configurations of the mitral valve lattice. The
valve trampoline has a cylindrical central region comprising valve
leaflets. An outwardly flaring implant skirt is attached to the
mitral valve lattice exterior. Wall-retaining wires are attached to
the mitral valve lattice, are petal-shaped, and have a pre-set,
radially outward, memory shape. The wires and skirt impart a force
on a respective side of the native mitral valve when the mitral
valve lattice is expanded within an annulus of the native mitral
valve.
Inventors: |
Cartledge; Richard (Boca Raton,
FL), Deville; Derek Dee (Coral Gables, FL), Smith; Kevin
W. (Coral Gables, FL), Greene; James L. (Stowe,
GB), Jimenez; Jorge (Atlanta, GA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences CardiAQ, LLC |
Irvine |
CA |
US |
|
|
Assignee: |
Edwards Lifesciences CardiAQ
LLC (Irvine, CA)
|
Family
ID: |
57585769 |
Appl.
No.: |
15/189,786 |
Filed: |
June 22, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20160367360 A1 |
Dec 22, 2016 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62183451 |
Jun 23, 2015 |
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62182820 |
Jun 22, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/2418 (20130101); A61F 2/2436 (20130101); A61F
2250/0048 (20130101); A61F 2230/0006 (20130101); A61F
2230/0034 (20130101); A61F 2230/0052 (20130101); A61F
2220/0016 (20130101); A61F 2250/001 (20130101); A61F
2250/0039 (20130101); A61F 2/2412 (20130101) |
Current International
Class: |
A61F
2/24 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
2304325 |
|
Oct 2000 |
|
CA |
|
2827556 |
|
Jul 2012 |
|
CA |
|
102006052564 |
|
Dec 2007 |
|
DE |
|
1171059 |
|
Jan 2002 |
|
EP |
|
1369098 |
|
Dec 2003 |
|
EP |
|
1259194 |
|
Feb 2005 |
|
EP |
|
1255510 |
|
Apr 2007 |
|
EP |
|
1827558 |
|
Sep 2007 |
|
EP |
|
1239901 |
|
Oct 2007 |
|
EP |
|
1472996 |
|
Sep 2009 |
|
EP |
|
1935377 |
|
Mar 2010 |
|
EP |
|
2238947 |
|
Oct 2010 |
|
EP |
|
2308425 |
|
Apr 2011 |
|
EP |
|
2398543 |
|
Dec 2011 |
|
EP |
|
1281375 |
|
Feb 2012 |
|
EP |
|
2496182 |
|
Sep 2012 |
|
EP |
|
2285317 |
|
Dec 2012 |
|
EP |
|
2566416 |
|
Mar 2013 |
|
EP |
|
2319458 |
|
Apr 2013 |
|
EP |
|
2124826 |
|
Jul 2014 |
|
EP |
|
2750630 |
|
Jul 2014 |
|
EP |
|
2777617 |
|
Sep 2014 |
|
EP |
|
2745805 |
|
Jun 2015 |
|
EP |
|
2749254 |
|
Jun 2015 |
|
EP |
|
2898858 |
|
Jul 2015 |
|
EP |
|
1734903 |
|
Oct 2015 |
|
EP |
|
2926766 |
|
Oct 2015 |
|
EP |
|
2967858 |
|
Jan 2016 |
|
EP |
|
2985006 |
|
Feb 2016 |
|
EP |
|
2168536 |
|
Apr 2016 |
|
EP |
|
2815725 |
|
Apr 2016 |
|
EP |
|
2237746 |
|
May 2016 |
|
EP |
|
2815723 |
|
Jul 2016 |
|
EP |
|
2262451 |
|
May 2017 |
|
EP |
|
3184083 |
|
Jun 2017 |
|
EP |
|
2446915 |
|
Jan 2018 |
|
EP |
|
3057541 |
|
Jan 2018 |
|
EP |
|
3037064 |
|
Mar 2018 |
|
EP |
|
3046511 |
|
Mar 2018 |
|
EP |
|
3142603 |
|
Mar 2018 |
|
EP |
|
3294220 |
|
Mar 2018 |
|
EP |
|
1264471 |
|
Feb 1972 |
|
GB |
|
1315844 |
|
May 1973 |
|
GB |
|
2398245 |
|
Aug 2004 |
|
GB |
|
2002540889 |
|
Dec 2002 |
|
JP |
|
2008541865 |
|
Nov 2008 |
|
JP |
|
0061034 |
|
Oct 2000 |
|
WO |
|
03092554 |
|
Nov 2003 |
|
WO |
|
2004030569 |
|
Apr 2004 |
|
WO |
|
2005011534 |
|
Feb 2005 |
|
WO |
|
2006070372 |
|
Jul 2006 |
|
WO |
|
2006085225 |
|
Aug 2006 |
|
WO |
|
2006089236 |
|
Aug 2006 |
|
WO |
|
2006127765 |
|
Nov 2006 |
|
WO |
|
2007025028 |
|
Mar 2007 |
|
WO |
|
2007058857 |
|
May 2007 |
|
WO |
|
2007123658 |
|
Nov 2007 |
|
WO |
|
2008013915 |
|
Jan 2008 |
|
WO |
|
2008070797 |
|
Jun 2008 |
|
WO |
|
2008103722 |
|
Aug 2008 |
|
WO |
|
2008125153 |
|
Oct 2008 |
|
WO |
|
2008150529 |
|
Dec 2008 |
|
WO |
|
2009026563 |
|
Feb 2009 |
|
WO |
|
2009033469 |
|
Mar 2009 |
|
WO |
|
2009045331 |
|
Apr 2009 |
|
WO |
|
2009053497 |
|
Apr 2009 |
|
WO |
|
2009091509 |
|
Jul 2009 |
|
WO |
|
2009094500 |
|
Jul 2009 |
|
WO |
|
2009134701 |
|
Nov 2009 |
|
WO |
|
2010005524 |
|
Jan 2010 |
|
WO |
|
2010008549 |
|
Jan 2010 |
|
WO |
|
2010022138 |
|
Feb 2010 |
|
WO |
|
2010037141 |
|
Apr 2010 |
|
WO |
|
2010040009 |
|
Apr 2010 |
|
WO |
|
2010057262 |
|
May 2010 |
|
WO |
|
2011025945 |
|
Mar 2011 |
|
WO |
|
2011057087 |
|
May 2011 |
|
WO |
|
2011111047 |
|
Sep 2011 |
|
WO |
|
2011137531 |
|
Nov 2011 |
|
WO |
|
2012177942 |
|
Dec 2012 |
|
WO |
|
2013028387 |
|
Feb 2013 |
|
WO |
|
2013059747 |
|
Apr 2013 |
|
WO |
|
2013075215 |
|
May 2013 |
|
WO |
|
WO 2013/106585 |
|
Jul 2013 |
|
WO |
|
2013120181 |
|
Aug 2013 |
|
WO |
|
2013175468 |
|
Nov 2013 |
|
WO |
|
2013192305 |
|
Dec 2013 |
|
WO |
|
2014018432 |
|
Jan 2014 |
|
WO |
|
2014099655 |
|
Jun 2014 |
|
WO |
|
2014110019 |
|
Jul 2014 |
|
WO |
|
2014110171 |
|
Jul 2014 |
|
WO |
|
2014121042 |
|
Aug 2014 |
|
WO |
|
2014139545 |
|
Sep 2014 |
|
WO |
|
2014145338 |
|
Sep 2014 |
|
WO |
|
2014149865 |
|
Sep 2014 |
|
WO |
|
2014163706 |
|
Oct 2014 |
|
WO |
|
2014164364 |
|
Oct 2014 |
|
WO |
|
2014194178 |
|
Dec 2014 |
|
WO |
|
2014204807 |
|
Dec 2014 |
|
WO |
|
2014205064 |
|
Dec 2014 |
|
WO |
|
2015077274 |
|
May 2015 |
|
WO |
|
2015148241 |
|
Oct 2015 |
|
WO |
|
2016016899 |
|
Feb 2016 |
|
WO |
|
2016065158 |
|
Apr 2016 |
|
WO |
|
2017096157 |
|
Jun 2017 |
|
WO |
|
Other References
Boudjemline, Younes, et al., "Steps Toward the Percutaneous
Replacement of Atrioventricular Valves," JACC, vol. 46, No. 2, Jul.
19, 2005:360-5. cited by applicant .
Spillner, J. et al., "New Sutureless `Atrial- Mitral-Valve
Prosthesis` for Minimally Invasive Mitral Valve Therapy," Textile
Research Journal, 2010, in 7 pages, Applicant believes this may
have been available as early as Aug. 9, 2010. cited by applicant
.
Karimi, Houshang, et al., "Percutaneous Valve Therapies," SIS 2007
Yearbook, Chapter 11, pp. 1-11. cited by applicant .
Lutter, Georg, et al., "Off-Pump Transapical Mitral Valve
Replacement," European Journal of Cardio-thoracic Surgery 36 (2009)
124-128, Applicant believes this may have been available as early
as Apr. 25, 2009. cited by applicant .
Ma, Liang, et al., "Double-Crowned Valved Stents for Off-Pump
Mitral Valve Replacement," European Journal of Cardio-thoracic
Surgery 28 (2005) 194-199, Applicant believes this may have been
available as early as Aug. 2005. cited by applicant .
Pluth, James R., M.D., et al., "Aortic and Mitral Valve Replacement
with Cloth-Covered Braunwald-Cutter Prosthesis, A Three-Year
Follow-up," The Annals of Thoracic Surgery, vol. 20, No. 3, Sep.
1975, pp. 239-248. cited by applicant .
Dave Fornell, "Transcatheter Mitral Valve replacement Devices in
Development," Diagnostic and Interventional Cardiology, Dec. 30,
2014, p. 3,
<http://www.dicardiology.com/article/transcatheter-mitral-valve-rep-
lacement-devices-development>. cited by applicant .
NJ350: Vote for Your Favorite New Jersey Innovations, Jun. 27,
2014,
http://www.kilmerhouse.com/2014/06/nj350-vote-for-your-favorite-new-jerse-
y-innovations/. cited by applicant .
Mack, Michael M.D., "Advantages and Limitations of Surgical Mitral
Valve Replacement; Lessons for the Transcatheter Approach,"
Applicant believes this may have been available as early as Jun. 7,
2010. Applicant believes this may have been presented at the Texas
Cardiovascular Innovative Ventures (TCIV) Conference in Dallas, TX
on Dec. 8, 2010. cited by applicant .
Bavaria, Joseph E. M.D. et al.: "Transcatheter Mitral Valve
Implantation: The Future Gold Standard for MR?," Applicant requests
the Examiner to consider this reference to be prior art as of Dec.
of 2010. cited by applicant .
Int'l. Search Report for PCT/US2016/038776, dated Sep. 15, 2016.
cited by applicant.
|
Primary Examiner: Snow; Bruce E
Attorney, Agent or Firm: Klarquist Sparkman, LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application: claims the priority, under 35 U.S.C. .sctn. 119,
of U.S. Provisional Patent Application No. 62/182,820, filed Jun.
22, 2015; and claims the priority, under 35 U.S.C. .sctn. 119, of
U.S. Provisional Patent Application No. 62/183,451, filed Jun. 23,
2015; the prior applications are herewith incorporated by reference
herein in their entireties.
Claims
What is claimed is:
1. A mitral valve implant, comprising: an expandable mitral valve
lattice having an inflow end portion and an outflow end portion; a
self-expanding valve trampoline lattice attached to the outflow end
portion of the mitral valve lattice; a self-expanding skirt lattice
attached to an exterior surface of the mitral valve lattice,
wherein the skirt lattice is covered by a fluid-resistant material;
and a plurality of jack screws rotatably connected to the mitral
valve lattice, wherein the mitral valve lattice is configured to
self-expand from a compressed configuration to a first expanded
configuration, and wherein the jack screws are configured to expand
the mitral valve lattice from the first expanded configuration to a
second expanded configuration, which is radially larger than the
first expanded configuration.
2. The implant according to claim 1, wherein the first expanded
configuration is one of circular and D-shaped.
3. The implant according to claim 2, wherein the second expanded
configuration corresponds in shape to the one of circular and
D-shaped first expanded configuration.
4. The implant according to claim 1, wherein the jack screws are
configured to compress the mitral valve lattice from the second
expanded configuration to the first expanded configuration.
5. The implant according to claim 1, wherein the mitral valve
lattice is made of a shape memory material and is shape-set to the
first expanded configuration.
6. The implant according to claim 1, wherein the valve trampoline
lattice has a cylindrical central region comprising valve
leaflets.
7. The implant according to claim 6, wherein the valve trampoline
lattice comprises a D-shaped portion.
8. The implant according to claim 7, wherein: the valve leaflets
have an inflow side; and the D-shaped portion is located on an
inflow side of the valve leaflets.
9. The implant according to claim 1, wherein the skirt lattice has
an outflow end portion that extends radially outwardly relative to
the mitral valve lattice and has a first outer diameter, and
wherein the first outer diameter of the skirt lattice is larger
than a second outer diameter of the valve trampoline lattice.
10. The implant according to claim 9, wherein the skirt lattice has
an inflow end portion comprising wall-retaining wires extending
radially outwardly relative to the mitral valve lattice, wherein
the wall-retaining wires are shaped to be positioned on a side of
the native mitral valve.
11. The implant according to claim 10, wherein the wall-retaining
wires are in the shape of petals and have a pre-set, radially
outward, memory shape to impart a force on the side of the native
mitral valve when the mitral valve lattice is expanded within an
annulus of the native mitral valve.
12. The implant according to claim 11, wherein: the outflow end
portion of the skirt lattice is shaped to be positioned on a
ventricular side of the native mitral valve when the mitral valve
lattice is expanded within the annulus of the native mitral valve;
and the wall-retaining wires of the skirt lattice are shaped to be
positioned on an atrial side of the native mitral valve when the
mitral valve lattice is expanded within the annulus of the native
mitral valve.
13. The implant according to claim 1, wherein the valve trampoline
lattice has an inflow end portion attached to the outflow end
portion of the mitral valve lattice, and wherein the skirt lattice
has an outflow end portion that has a larger diameter than
diameters of the inflow end portions of the mitral valve lattice
and the valve trampoline lattice.
14. The implant according to claim 1, wherein when the mitral valve
lattice is in the second expanded configuration, an outflow end
portion of the valve trampoline lattice is spaced radially inwardly
from the outflow end of the mitral valve lattice.
Description
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
FIELD OF THE INVENTION
The present invention lies in the field of heart valve implants
(including mitral, aortic, pulmonary, and tricuspid), and methods
and systems for controlling and implanting heart valves.
BACKGROUND OF THE INVENTION
The human heart can suffer from various valvular diseases, which
can result in significant malfunctioning of the heart and
ultimately require replacement of the native heart valve with an
artificial valve. There are a number of known artificial valves and
a number of known methods of implanting these artificial valves in
humans.
One method of implanting an artificial heart valve in a human
patient is via open-chest surgery, during which the patient's heart
is stopped and the patient is placed on cardiopulmonary bypass
(using a so-called "heart-lung machine"). In one common surgical
procedure, the diseased native valve leaflets are excised and a
prosthetic valve is sutured to the surrounding tissue at the native
valve annulus. Because of the trauma associated with the procedure
and the attendant duration of extracorporeal blood circulation,
some patients do not survive the surgical procedure or die shortly
thereafter. It is well known that the risk to the patient increases
with the amount of time required on extracorporeal circulation. Due
to these risks, a substantial number of patients with defective
native valves are deemed inoperable because their condition is too
frail to withstand the procedure.
Because of the drawbacks associated with conventional open-chest
surgery, percutaneous and minimally-invasive surgical approaches
are in some cases preferred. In one such technique, a prosthetic
valve is configured to be implanted in a much less invasive
procedure by way of catheterization. For instance, U.S. Pat. Nos.
7,393,360, 7,510,575, and 7,993,394 describe collapsible
transcatheter prosthetic heart valves that can be percutaneously
introduced in a compressed state on a catheter and expanded to a
functional size at the desired position by balloon inflation or by
utilization of a self-expanding frame or stent.
Various heart valve replacement devices exist in the art and,
during the past decade, advancements in valve replacement implants
have been achieved. Many of these advancements have occurred with
those implants delivered percutaneously in a compressed state on a
catheter and, with outer sheath retraction, self-expand to a given
extent for implantation. Some implants are made of entirely
self-expanding structures. Other implants partially self-expand and
then are further expanded by force. Such dual-expansion implants
can be made from a single, substantially cylindrical, lattice
structure having a pre-defined (e.g., heat-set) initial shape that
is smaller than the intended implantation diameter of an anatomic
orifice, such as a vessel or heart valve. The lattice can be made
of nitinol, for example. A lattice of non-self-expanding material
can also be used, for example, of a cobalt chromium material.
Within the lattice there can be a set of adjustable expansion
devices that place respective forces upon the lattice to
elastically and/or plastically deform the lattice to a size that is
even greater than the pre-defined shape. One example of the
expansion devices is a set of jack screws that are controlled by
rotating drive wires (which wires extend from the implant location
to the environment outside the patient and terminate, for example,
at an electronic delivery control handle). As shown in U.S. Patent
Application Publication Nos. 2013/0046373, 2013/0166017, and
2014/0296962, these rotating wires are initially connected to a
respective jack screw and rotation of each wire causes a
corresponding rotation of the jack screw. With the jack screws
being connected to the lattice on each of their opposing ends (for
example, through a threaded connection on one end and a freely
rotating but longitudinally fixed connection on the other),
rotation in one direction expands the circumference of the lattice
and rotation in the other direction contracts the lattice. These
control wires can be connected to the delivery handle with
temporary securement structures that keep the wires rotationally
connected to the respective jack screw until implantation and
release of the replacement valve is desired. Before being
disconnected, the control wires can reversibly expand and contract
the lattice as the surgeon desires for optimal placement in the
installation location. In other words, such implants can be
repositioned before final deployment. When the implant is
positioned in a final desired orientation, the drive wires are
disconnected from all of the jack screws and are removed from the
patient.
One advantage that such implants have over entirely self-expanding
lattices is that these implants can be carefully expanded and also
can provide feedback to the operator as to the device diameter and
forces encountered from surrounding tissue. In contrast, entirely
self-expanding implants continuously expand and apply an outwardly
directed force where the lattice is implanted. The final diameter
of the implant is not finely controllable or adjustable. Expansion
of the tissue could lead to paravalvular leakage, movement of the
implant, and/or embolism, all of which are undesirable.
Another feature of lattice implants that, upon deployment, first
self-expand when removed from the installation catheter and then
are forcibly expanded into the delivery site (referred to as
self-expanding/forcibly expanding) is the fact that the force
imparted against the tissue can be measured (and/or calculated) and
either minimized or set to a desired value. While rotating the
drive wires, any torque applied to the drive wires can be measured
and determined with an implant delivery and deployment system
having sensors (e.g., electronic sensors) that measure various
parameters, such as current draw for example. Rotation of the drive
wires for expanding the implant can be halted when a value of the
determined torque is reached.
Delivery of implants in the art for replacement or repair of a
heart valve can be achieved over different avenues. One
percutaneous way that implant delivery can occur is through the
aorta, where the entry site in the patient is located adjacent the
femoral artery, referred to as the transfemoral (TF) approach.
Another route to implantation of a replacement valve is through a
transapical approach. Aortic replacement valves installed in these
manners are referred to as Transcatheter Aortic Valve Replacement
(TAVR) and Transcatheter Aortic Valve Implantation (TAVI)
surgeries, which can be transapical. A third path through the
septum of the heart is also possible and one such procedure is
referred as a Transseptal (TS) Antegrade Transcatheter Aortic Valve
Replacement.
For the treatment of mitral valve disease, Transcatheter Mitral
Valve Replacement (TMVR) has been the subject of study, but has not
been widely commercialized. Current TMVR techniques have several
limitations. First, the size of the valves that are available for
TMVR implant may not fit well. In particular, the mitral valve is
not substantially circular, it has a D-shape with a long curving
interface between the mitral valve's native leaflets. This is in
contrast to the aortic valve, which is substantially circular.
Also, the TMVR devices do not tend to allow for repositioning of
the implant once it has been deployed in place. Next, the final
expanded diameter of the known TMVR devices is pre-determined,
making pre-sizing by a doctor a critical and difficult step. The
physician must remotely assess the size of the diseased valve for
selecting the correct implant. Migration of existing mitral valve
implants is a significant clinical problem, potentially causing
leakage and/or compromising necessary vascular supply. In such
situations, emergency open surgery can be required, and/or it can
lead to an unstable seal and/or migration.
No commercially approved transcatheter mitral valve exists. Some
are being studied but there is no replacement mitral valve that can
be fully repositioned during deployment and adjusted to better
accommodate and seal a natural, diseased mitral valve. Thus, a need
exists to overcome the problems with the prior art systems,
designs, and processes as discussed above.
SUMMARY OF THE INVENTION
Embodiments of the systems, apparatuses, and methods described
herein relate to an actively controllable implant or heart valve
implant and methods of controlling same that overcome the
hereinafore-mentioned disadvantages of the heretofore-known devices
and methods of this general type and that provide such features
with the ability to be fully repositioned before final
deployment.
Described herein are various systems, apparatuses, and methods for
implanting replacement heart valves, which implants can be used in
any valve of the heart. In some exemplary embodiments herein,
implants for a stent graft, a valve, a mitral valve and associated
system, apparatuses, and methods are shown and described.
As compared to other heart valves, in a diseased mitral valve, the
tissue is relatively soft. This means that prior art self-expanding
mitral implant valves which are oversized relative to the native
mitral valve continuously provide an outward expanding force to the
native mitral valve tissue. This force further expands the diseased
tissue throughout the life of the implant. Such a result is not
desirable for many reasons, e.g., leakage, movement, and/or
embolization. Provided herein in some exemplary embodiments are
heart valve (e.g., mitral valve) replacement implants that do not
continuously provide an outwardly directed force after
implantation. These implants have a self-expansion aspect but that
self-expansion occurs only for a certain extent--before or up to
the native annulus of tissue surrounding the mitral valve. After
the self-expansion occurs, the adjustable stent lattice portion of
the implant is then forcibly expanded into the native annulus only
to an extent to seat the implant within the annulus with no leakage
occurring around the implant. This means that, when a correct and
sufficient implanted status occurs, there will be no additional
outwardly directed force imparted on the native annulus by the
implant to cause further outwards expansion of that tissue over the
life of the implant. This advantage over the prior art permits
greater longevity. Also provided in some of the exemplary
embodiments are optional structures that ensure a fluid-tight seal
against each of the two sides of the valve being replaced. One
exemplary implant-securing structure is a self-expanding, implant
skirt attached to the adjustable stent lattice, having a material
that is fluid-tight or resistant (or after being installed becomes
fluid-tight), and, when released from the delivery catheter,
springing open to occlude the side of the valve on which it
resides. It essentially is in the form of an umbrella that contacts
the side of the implant site on its entire circumference. Another
independent exemplary implant-securing structure is a set of
self-expanding, wall-retaining petals. These petals can be
compressed within delivery wires while the implant is installed in
the delivery catheter, can continue to be held radially inwards by
the delivery wires, while the implant is being maneuvered and
installed in an implant site, and spring open radially away from
the central longitudinal axis of the implant when the delivery
wires are released from the implant upon final deployment. In this
way, the implant is adjustable and repositionable repeatedly in
both the expansion and contraction directions up until final
deployment. With both implant-securing structures on opposing sides
of the implant, the petals, the implant skirt, and the adjustable
stent lattice form an annulus having a concave U-shape that can
entirely capture and hold therein the native valve annulus in a
fluid-tight and leak-tight manner.
A further advantage of some of the embodiments of herein-described
mitral valve implants relates to the size of the valve portion when
the implant is secured in the native annulus. The native annulus of
mitral valves are substantially D-shaped. One characteristic of a
diseased mitral valve is that the annulus stretches outwardly,
leaving the leaflets of the mitral valve unable to coapt and,
thereby, impairing the functionality of the valve. In what is
referred to as Mitral Valve Prolapse, one or both of the valve
flaps are enlarged and do not close in an even manner. With
improper closure, blood could flow backwards into the left atrium,
referred to as Mitral Valve Regurgitation. With a stretching of the
mitral valve annulus, even if a prior art implant is able to be
secured therein, the size of that implant's valve opening may be
too large for the patient. Some of the embodiments of the mitral
valve implant herein provide a valve opening sized for optimal flow
irrespective of the size of the diseased mitral valve annulus.
These embodiments provide a fixed-sized valve opening contained
within a variable outer annular skirt, the combined structures of
the variably sized outer skirt and the fixed-sized valve being
referred to herein as a trampoline valve. These exemplary implants,
therefore, provide an ideal amount of flow through the valve of the
implant in spite of the enlarged native mitral valve annulus. This
means that, regardless of the final D-shaped diameter of the
implanted stent lattice, the trampoline valve will have its own
fixed maximum circular diameter, which improves valve function and
durability. This feature allows a standard-sized valve to cover a
large patient population with mitral valves of various sizes. The
skirt can optionally have a downstream flair that creates a back
seal when high pressure of ventricle contraction is imparted.
With the foregoing and other objects in view, there is provided, a
mitral valve implant comprising a force-expanding mitral valve
lattice having an interior orifice and a self-expanding valve
trampoline attached at the interior orifice of the force-expanding
mitral valve lattice.
With the objects in view, there is also provided a mitral heart
valve implant system comprising a valve delivery system, a
self-expanding and forcibly expanding mitral valve frame, a
self-expanding implant skirt, wall-retaining wires, and a
self-expanding valve trampoline lattice. The valve delivery system
comprises a controller, a guidewire lumen connected to the
controller and having a distal nosecone, a hollow external sheath
surrounding the guidewire lumen, having a proximal end connected to
the controller, and configured to retract proximally from an
extended, valve-installed position, a given number of implant drive
wires each having a distal drive wire connector, and hollow
connector lumens equal in number to the given number and each
respectively threaded on one of the drive wires and having a distal
hollow connector sleeve. The self-expanding and forcibly expanding
mitral valve frame defines a central axis and comprises proximal
and distal jack screw strut pairs equal in number to the given
number and disposed parallel to the central axis, intermediate
struts equal in number to the given number and disposed parallel to
the central axis, each intermediate strut disposed between two
adjacent ones of the jack screw strut pairs, arms respectively
connecting adjacent ones of the jack screw strut pairs and the
intermediate struts, and a plurality of jack screws. The jack
screws are each rotatably connected to one jack screw strut pair,
form, together with the jack screw strut pairs, the intermediate
struts, and the arms, an adjustable stent lattice having a
ventricle side and an atrial side, are configured to reversibly
forcibly expand and contract the adjustable stent lattice between a
compressed state and an enlarged state for implantation of the
mitral valve frame into a native mitral valve, and each have a
driving connector shaped to removably mate and connect to the
distal drive wire connector of one of the drive wires and be held
connected thereto when the hollow connector sleeve is disposed
about the mated driving connector and distal drive wire connector
such that rotation of the drive wires correspondingly rotates the
jack screws to forcibly expand or contract the adjustable stent
lattice. The self-expanding implant skirt is attached to the
ventricle side of the adjustable stent lattice. The implant skirt
is configured to compress and be stored inside the external sheath
and, when released from the external sheath at a native mitral
valve, to self-expand and sealably position on tissue at a
ventricular side of the native mitral valve. The wall-retaining
wires are attached to the atrium side of the adjustable stent
lattice and are configured to compress and be stored inside the
external sheath and, when released from the external sheath at a
native mitral valve, to self-expand on tissue at an atrial side of
the native mitral valve. The self-expanding valve trampoline
lattice is disposed inside and is connected to the adjustable stent
lattice and comprises an expandable outer trampoline portion having
a circumferential exterior connected to the interior of the
adjustable stent lattice and a circumferential interior and an
inner circumferential valve portion connected to the
circumferential interior and extending inwardly from the
circumferential interior to define an interior cylindrical portion
and having a circular valve with internal valve leaflets disposed
at the interior cylindrical portion.
With the objects in view, there is also provided a mitral heart
valve implant system comprises a mitral valve lattice having a
pre-set D-shaped cross-sectional configuration, defining an
internal orifice, and comprising a plurality of jack screws
configured to forcibly expand and contract the mitral valve lattice
reversibly between a compressed configuration and an enlarged
configuration, an outwardly flaring, self-expanding implant skirt
attached to an exterior of the mitral valve lattice, the implant
skirt shaped to be positioned on a ventricular side of a native
mitral valve to secure the mitral valve lattice in the annulus of
the native mitral valve, radially outwardly biased wall-retaining
wires attached to the mitral valve lattice and shaped to be
positioned on an atrial side of the native mitral valve to secure
the mitral valve lattice in the annulus of the native mitral valve,
a self-expanding valve trampoline lattice containing interior valve
leaflets, the valve trampoline lattice disposed within the internal
orifice of the mitral valve lattice and having a D-shape portion
attached to the mitral valve lattice and a substantially
cylindrical interior portion, wherein the valve leaflets are
attached to the substantially cylindrical interior portion, and a
delivery system comprising a plurality of implant drive wires
temporarily connectable to the jack screws such that, when
connected, rotation of the drive wires in one direction forcibly
expands the mitral valve lattice towards the enlarged configuration
and rotation of the drive wires in a direction opposite the one
direction forcibly contracts the mitral valve lattice towards the
compressed configuration.
With the objects in view, there is also provided a method for
implanting a mitral heart valve including the steps of contracting
a self-expanding and forcibly-expanding mitral valve of a
shape-memory material set to a given shape to a reduced
implantation size with a delivery system having drive wires, the
mitral valve having an adjustable assembly with adjustable elements
operatively connected to the drive wires such that, when the
adjustable elements are adjusted by the drive wires, a
configuration change in at least a portion of the mitral valve
occurs, inserting the contracted mitral valve into a native mitral
valve annulus in which the mitral valve is to be implanted,
rotating the drive wires with the delivery system to forcibly
expand the mitral valve into the native annulus, while rotating the
drive wires, determining with the delivery system a torque applied
to the drive wires, and stopping rotation of the drive wires based
upon a value of the determined torque.
In accordance with another feature, the force-expanding mitral
valve lattice is self-expandable to a first configuration and is
force expandable from the first configuration to a second
configuration.
In accordance with a further feature, the first configuration is
one of circular and D-shaped.
In accordance with an added feature, the second configuration
corresponds in shape to the one of circular and D-shaped first
configuration.
In accordance with an additional feature, the mitral valve lattice
comprises a plurality of jack screws configured to adjust expansion
and contraction of a configuration of the mitral valve lattice.
In accordance with yet another feature, the mitral valve lattice is
made of a shape memory material set shape to a given shape.
In accordance with yet a further feature, the valve trampoline has
a cylindrical central region comprising valve leaflets.
In accordance with yet an added feature, the valve trampoline
comprises a D-shaped portion.
In accordance with yet an additional feature, the valve leaflets
have an inflow side and the D-shaped portion is located on an
inflow side of the valve leaflets.
In accordance with again another feature, the mitral valve lattice
has an exterior and there is provided an outwardly flaring implant
skirt attached to the exterior of the mitral valve lattice and
shaped to be positioned on a side of a native mitral valve.
In accordance with again a further feature, there are provided
wall-retaining wires attached to the mitral valve lattice and
shaped to be positioned on a side of the native mitral valve.
In accordance with again an added feature, the wall-retaining wires
are in the shape of petals and have a pre-set, radially outward,
memory shape to impart a force on the side of the native mitral
valve when the mitral valve lattice is expanded within an annulus
of the native mitral valve.
In accordance with again an additional feature, the implant skirt
is a left ventricle implant skirt shaped to be positioned on a
ventricular side of the native mitral valve when the mitral valve
lattice is expanded within the annulus of the native mitral valve
and the wall-retaining wires are left-atrium wall-retaining wires
shaped to be positioned on an atrial side of the native mitral
valve when the mitral valve lattice is expanded within the annulus
of the native mitral valve.
In accordance with still another feature, the implant skirt is a
left atrium implant skirt shaped to be positioned on an atrial side
of the native mitral valve when the mitral valve lattice is
expanded within the annulus of the native mitral valve and the
wall-retaining wires are left-ventricle wall-retaining wires shaped
to be positioned on a ventricular side of the native mitral valve
when the mitral valve lattice is expanded within the annulus of the
native mitral valve.
In accordance with still a further feature, the mitral valve
lattice has an inlet end and an outlet end and the valve trampoline
is attached to the inlet end of the interior orifice.
In accordance with still an added feature, the mitral valve lattice
has an inlet end and an outlet end and the valve trampoline is
attached to the outlet end of the interior orifice.
In accordance with a concomitant feature, the adjustable stent
lattice has a pre-set D-shaped cross-section and the exterior of
the expandable outer trampoline portion is pre-set to a
circumferential D-shape.
Although the systems, apparatuses, and methods are illustrated and
described herein as embodied in an actively controllable heart
valve implant and methods of controlling same, it is, nevertheless,
not intended to be limited to the details shown because various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims. Additionally, well-known
elements of exemplary embodiments will not be described in detail
or will be omitted so as not to obscure the relevant details of the
systems, apparatuses, and methods.
Additional advantages and other features characteristic of the
systems, apparatuses, and methods will be set forth in the detailed
description that follows and may be apparent from the detailed
description or may be learned by practice of exemplary embodiments.
Still other advantages of the systems, apparatuses, and methods may
be realized by any of the instrumentalities, methods, or
combinations particularly pointed out in the claims.
Other features that are considered as characteristic for the
systems, apparatuses, and methods are set forth in the appended
claims. As required, detailed embodiments of the systems,
apparatuses, and methods are disclosed herein; however, it is to be
understood that the disclosed embodiments are merely exemplary of
the systems, apparatuses, and methods, which can be embodied in
various forms. Therefore, specific structural and functional
details disclosed herein are not to be interpreted as limiting, but
merely as a basis for the claims and as a representative basis for
teaching one of ordinary skill in the art to variously employ the
systems, apparatuses, and methods in virtually any appropriately
detailed structure. Further, the terms and phrases used herein are
not intended to be limiting; but rather, to provide an
understandable description of the systems, apparatuses, and
methods. While the specification concludes with claims defining the
systems, apparatuses, and methods of the invention that are
regarded as novel, it is believed that the systems, apparatuses,
and methods will be better understood from a consideration of the
following description in conjunction with the drawing figures, in
which like reference numerals are carried forward.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying figures, where like reference numerals refer to
identical or functionally similar elements throughout the separate
views, which are not true to scale, and which, together with the
detailed description below, are incorporated in and form part of
the specification, serve to illustrate further various embodiments
and to explain various principles and advantages all in accordance
with the systems, apparatuses, and methods. Advantages of
embodiments of the systems, apparatuses, and methods will be
apparent from the following detailed description of the exemplary
embodiments thereof, which description should be considered in
conjunction with the accompanying drawings in which:
FIG. 1 is a fragmentary, side perspective view of an exemplary
embodiment of a distal end of a delivery and deployment system for
an actively controllable heart valve implant;
FIG. 2 is a fragmentary, side perspective view of the distal end of
the delivery system of FIG. 1 with an exemplary embodiment of an
actively controllable mitral valve replacement implant, with an
implant skirt and a valve trampoline removed for clarity, in a
pre-installation orientation with an outer catheter covering
implant drive wires, with the drive wires connected to jack screws
of a self-expanding and forcibly-expanding valve lattice, with a
self-expanding valve trampoline lattice containing non-illustrated
valve leaflets within an orifice of the valve lattice and attached
to the valve lattice;
FIG. 3 is a fragmentary, side perspective view of the distal end of
the delivery system of FIG. 1 with the mitral valve replacement
implant of FIG. 2 in a pre-installation orientation with the outer
sheath retracted from the implant drive wires;
FIG. 4 is an enlarged, fragmentary, side perspective view of the
distal end of the delivery system of FIG. 1 with the mitral valve
replacement implant of FIG. 3 in a pre-installation orientation
with the mitral valve implant in a self-expanded, enlarged state,
with the implant skirt and the valve trampoline transparent;
FIG. 5 is a fragmentary, perspective view of the distal end of the
delivery system of FIG. 1 with the valve implant of FIG. 4 in a
pre-installation orientation with the valve implant in a forcibly
expanded, enlarged state;
FIG. 6 is a fragmentary, perspective view of the distal end of the
delivery system of FIG. 1 with the mitral valve replacement implant
of FIG. 5 in a fully-expanded, delivery orientation with the drive
wires still engaged to the implant and constraining atrium wall
retainers;
FIG. 7 is a fragmentary, perspective view of the distal end of the
delivery system of FIG. 1 with the mitral valve replacement implant
of FIG. 5 having the drive wires disengaged from the implant and
from the atrium wall-retaining structures;
FIG. 8 is a fragmentary, perspective view of the distal end of the
delivery system of FIG. 1 with the mitral valve replacement implant
of FIG. 7 having the drive wires in a further retracted position
from the implant and with the nosecone in a retracted state within
the implant;
FIG. 9 is a ventricle-side elevational view of the mitral valve
replacement implant of FIG. 8 with the mitral valve leaflets closed
and with the D-shape of the self-expanding valve trampoline lattice
visible;
FIG. 10 is an atrium-side elevational view of the mitral valve
replacement implant of FIG. 8 with the valve leaflets in an
almost-closed state;
FIG. 11 is a ventricle-side perspective view of the mitral valve
replacement implant of FIG. 9 with the valve leaflets partially
open;
FIG. 12 is an atrium-side perspective view of the mitral valve
replacement implant of FIG. 9 with the valve in a substantially
open state;
FIG. 13 is a side elevational view of the mitral valve replacement
implant of FIG. 15 with attachment points connecting the skirt
lattice and the skirt fabric to the adjustable stent lattice;
FIG. 14 is a fragmentary, perspective view of the delivery system
of FIG. 1 for the actively controllable mitral valve replacement
implant in a vertical cross-section of a human heart and with the
guidewire in the left ventricle and the nosecone entering the left
atrium of a ventricle-contracted heart;
FIG. 15 is a fragmentary, perspective view of the delivery system
of FIG. 14 with the nosecone in the left ventricle of a
ventricle-relaxed heart;
FIG. 16 is a fragmentary, perspective view of the delivery system
of FIG. 15 with the outer sheath withdrawn into the left atrium and
the mitral valve replacement implant beginning to show within a
ventricle-contracted heart;
FIG. 17 is a fragmentary, perspective view of the delivery system
of FIG. 16 with the outer sheath substantially withdrawn over the
mitral valve replacement implant and the implant skirt in a first
self-expanded orientation within the mitral valve orifice of a
ventricle-relaxed heart;
FIG. 18 is a fragmentary, perspective view of the delivery system
of FIG. 17 with the implant skirt in a second self-expanded
orientation within the mitral valve orifice and with the drive
wires of the mitral valve replacement implant partially visible
within a ventricle-contracted heart;
FIG. 19 is a fragmentary, perspective view of the delivery system
of FIG. 18 with the implant skirt in a third self-expanded
orientation within the mitral valve orifice and with the drive
wires of the mitral valve replacement implant visible within a
ventricle-contracted heart;
FIG. 20 is a fragmentary, perspective view of the delivery system
of FIG. 19 with the adjustable stent lattice in a forcibly expanded
orientation within the mitral valve orifice of a ventricle-relaxed
heart;
FIG. 21 is a fragmentary, perspective view of the delivery system
of FIG. 20 with the adjustable stent lattice and the implant skirt
in a fully expanded and implanted orientation within the mitral
valve orifice of a ventricle-contracted heart before disconnection
of the drive wires;
FIG. 22 is a fragmentary, perspective view of an exemplary
embodiment of a sheath-constrained mitral valve replacement implant
within a mitral valve orifice viewed from the left atrium with the
mitral valve partially open, with the drive wires fully
constraining the atrium retaining petals, and with the outer
delivery sheath removed;
FIG. 23 is a fragmentary, perspective view of the
sheath-constrained mitral valve replacement implant of FIG. 22 with
the mitral valve fully open;
FIG. 24 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 23 with the sheath retracted and with
the skirt of the mitral valve replacement implant in a
self-expanded state with the mitral valve fully open and with the
drive wires constraining the atrium retaining petals;
FIG. 25 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 24 with the mitral valve closed upon
the skirt of the valve implant;
FIG. 26 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 25 in a fully self-expanded state with
the mitral valve closed upon the mitral valve replacement
implant;
FIG. 27 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 26 in a forcibly expanded state with
the mitral valve partially open around the mitral valve replacement
implant and with the replacement valve of the mitral valve
replacement implant partially open;
FIG. 28 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 27 in still a further forcibly expanded
state with the mitral valve partially closed around the mitral
valve replacement implant and with the replacement valve of the
mitral valve replacement implant almost fully open;
FIG. 29 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 28 in yet a further forcibly expanded
state with the mitral valve open around the mitral valve
replacement implant and with the replacement valve of the mitral
valve replacement implant fully open;
FIG. 30 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 29 in another forcibly expanded state
with the mitral valve open around the mitral valve replacement
implant and with the replacement valve of the mitral valve
replacement implant partially open;
FIG. 31 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 30 with the mitral valve closed around
the mitral valve replacement implant and with the replacement valve
of the mitral valve replacement implant closed around the delivery
guidewire lumen;
FIG. 32 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 31 held open by the mitral valve
replacement implant in a valve-implanted state and with the
replacement valve of the mitral valve replacement implant in an
almost fully open state;
FIG. 33 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 32 with the mitral valve replacement
implant in the valve-implanted state and with the drive wire
assembly retracted and disengaged to no longer constrain the atrium
retaining petals;
FIG. 34 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 33 with the mitral valve replacement
implant in the valve-implanted state, with the drive wire assembly
disengaged and further retracted, and with the atrium retaining
petals retained against the wall of the left atrium;
FIG. 35 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 34 with the mitral valve replacement
implant in the valve-implanted state, with the replacement valve of
the mitral valve replacement implant in an open state, and with the
drive wire assembly completely retracted;
FIG. 36 is a fragmentary, perspective view of the mitral valve
replacement implant of FIGS. 9 to 13 in a skirt-and-valve-expanded
state approximately equivalent to the view of the mitral valve
replacement implant of FIG. 26 and with the replacement valve in a
substantially open state;
FIG. 37 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 36 in a skirt-and-valve-expanded state
approximately equivalent to the view of the mitral valve
replacement implant of FIG. 27 and with the replacement valve in an
almost closed state;
FIG. 38 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 37 in a skirt-and-valve-expanded state
approximately equivalent to the view of the mitral valve
replacement implant of FIG. 29 and with the replacement valve in a
partially open state;
FIG. 39 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 38 in a skirt-and-valve-expanded state
between the views of the mitral valve replacement implant of FIGS.
31 and 32 and with the replacement valve in a substantially closed
state;
FIG. 40 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 39 in a valve-implanted state
approximately equivalent to the view of the mitral valve
replacement implant of FIG. 33 with the replacement valve in a
substantially open state and with the drive wires disengaged from
the mitral valve replacement implant;
FIG. 41 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 40 with the drive wires removed and
with the nosecone partially retracted;
FIG. 42 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 41 with the nosecone retracted
partially through and closed upon by the leaflets of the mitral
valve replacement implant;
FIG. 43 is a fragmentary, perspective view of the mitral valve
replacement implant of FIG. 42 with the nosecone withdrawn from the
mitral valve replacement implant and with the replacement valve in
a substantially open state;
FIG. 44 is a fragmentary, perspective view of an embodiment of an
actively controllable delivery or deployment system for an
adjustable stent graft;
FIG. 45 is a fragmentary, perspective view of another exemplary
embodiment of an actively controllable stent graft connected to the
delivery system of FIG. 44 in a partially expanded state;
FIG. 46 is a fragmentary, perspective view of the stent graft of
FIG. 45 in a fully expanded and ready-to-implant state;
FIG. 47 is a fragmentary, perspective view of the stent graft of
FIG. 46 implanted at a target area with tissue-engagement hooks
deployed;
FIG. 48 is a fragmentary, vertically cross-sectional and
perspective view of the delivery system of FIG. 44 inserted through
the apex of the heart and through the mitral valve annulus into the
left atrium;
FIG. 49 is a fragmentary, vertically cross-sectional and
perspective view of the heart of FIG. 48 with the delivery system
deploying the stent graft of FIG. 45 as a replacement mitral valve
implant with the implant partially expanded in the mitral valve
annulus;
FIG. 50 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 49;
FIG. 51 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 49 with the delivery system
having deployed hooks of the implant into the mitral valve
annulus;
FIG. 52 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 51 with the delivery system
removed from the heart and the implant secured in the mitral valve
annulus;
FIG. 53 is a fragmentary, perspective view of the actively
controllable delivery system of FIG. 44;
FIG. 54 is a fragmentary, perspective view of another exemplary
embodiment of an actively controllable heart valve replacement
implant connected to the delivery system of FIG. 53 in a partially
expanded state with the inner valve assembly removed;
FIG. 55 is a fragmentary, perspective view of the heart valve
replacement implant of FIG. 54 in a fully expanded and
ready-to-implant state with interior portions of the inner valve
assembly removed;
FIG. 56 is a fragmentary, perspective view of the heart valve
replacement implant of FIG. 55 implanted at a target area with
tissue-engagement hooks and a skirt deployed and with interior
portions of the inner valve assembly removed;
FIG. 57 is a fragmentary, top plan view of the heart valve
replacement implant of FIG. 56 implanted at a target area with
tissue-engagement hooks and a skirt deployed and with interior
portions of the inner valve assembly;
FIG. 58 is a fragmentary, vertically cross-sectional and
perspective view of the delivery system of FIG. 44 inserted through
the apex of the heart and through the mitral valve annulus into the
left atrium;
FIG. 59 is a fragmentary, vertically cross-sectional and
perspective view of the heart of FIG. 58 with the delivery system
deploying the replacement mitral valve implant of FIG. 57 with the
implant partially expanded in the mitral valve annulus;
FIG. 60 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 59;
FIG. 61 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 60 with the delivery system
having deployed hooks of the implant into the mitral valve
annulus;
FIG. 62 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 61 with the delivery system
removed from the heart and the implant secured in the mitral valve
annulus;
FIG. 63 is a fragmentary, perspective view of the actively
controllable delivery system of FIG. 44;
FIG. 64 is a fragmentary, perspective view of another exemplary
embodiment of an actively controllable heart valve replacement
implant connected to the delivery system of FIG. 63 in a partially
expanded state with the inner valve assembly removed;
FIG. 65 is a fragmentary, perspective view of the heart valve
replacement implant of FIG. 64 in a fully expanded and
ready-to-implant state with interior portions of the inner valve
assembly removed;
FIG. 66 is a fragmentary, perspective view of the heart valve
replacement implant of FIG. 65 implanted at a target area with
tissue-engagement hooks and an upstream skirt deployed and with
interior portions of the inner valve assembly removed;
FIG. 67 is a fragmentary, top plan view of the heart valve
replacement implant of FIG. 66 implanted at a target area with
tissue-engagement hooks, an upstream skirt, and a trampoline valve
deployed and with valve leaflets removed;
FIG. 68 is a fragmentary, vertically cross-sectional and
perspective view of the delivery system of FIG. 44 inserted through
the apex of the heart and through the mitral valve annulus into the
left atrium;
FIG. 69 is a fragmentary, vertically cross-sectional and
perspective view of the heart of FIG. 68 with the delivery system
deploying the replacement mitral valve implant of FIG. 67 with the
implant partially expanded in the mitral valve annulus;
FIG. 70 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 69 with the leaflets removed
from the implant;
FIG. 71 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 70 with the delivery system
having deployed hooks of the implant into the mitral valve
annulus;
FIG. 72 is a fragmentary, horizontally cross-sectional and
perspective view of the heart of FIG. 71 with the delivery system
removed from the heart and the implant secured in the mitral valve
annulus;
FIG. 73 is an atrium-side elevational view of the mitral valve
replacement implant of FIGS. 64 to 67 and 69 to 72 with the valve
leaflets in an almost-closed state and with hook fasteners extended
radially outward;
FIG. 74 is a top plan view of an implant skirt frame and an
adjustable stent lattice of the mitral valve replacement implant of
FIG. 73;
FIG. 75 is a perspective view from a side of the skirt frame and
adjustable stent lattice of FIG. 74;
FIG. 76 is an atrium-side perspective view of another exemplary
embodiment of an actively controllable, mitral valve replacement
implant with an implant skirt, wall-retaining petals, and an
internal valve trampoline;
FIG. 77 is an atrium-side perspective view of an implant skirt
frame, wall-retaining petals, a valve trampoline lattice, and an
adjustable stent lattice of the mitral valve replacement implant of
FIG. 76;
FIG. 78 is a substantially side elevational view of the mitral
valve replacement implant of FIG. 76;
FIG. 79 is a substantially side elevational view of the implant
skirt frame, the wall-retaining petals, the valve trampoline
lattice, and the adjustable stent lattice of the mitral valve
replacement implant of FIG. 76;
FIG. 80 is a ventricle-side perspective view of the mitral valve
replacement implant of FIG. 76;
FIG. 81 is a ventricle-side perspective view of the implant skirt
frame, the wall-retaining petals, the valve trampoline lattice, and
the adjustable stent lattice of the mitral valve replacement
implant of FIG. 76;
FIG. 82 is an installation-side perspective view of another
exemplary embodiment of an actively controllable, trampoline-side
installed, circular valve replacement implant with an implant
skirt, covered opposing-side wall-retaining petals, and an internal
valve trampoline;
FIG. 83 is an installation-side perspective view of an implant
skirt frame, wall-retaining petals, a valve trampoline lattice, and
an adjustable stent lattice of the circular valve replacement
implant of FIG. 82;
FIG. 84 is a substantially side elevational view of the circular
valve replacement implant of FIG. 82;
FIG. 85 is a substantially side elevational view of the implant
skirt frame, the wall-retaining petals, the valve trampoline
lattice, and the adjustable stent lattice of the circular valve
replacement implant of FIG. 82;
FIG. 86 is a nosecone-side perspective view of the circular valve
replacement implant of FIG. 82;
FIG. 87 is a nosecone-side perspective view of the implant skirt
frame, the wall-retaining petals, the valve trampoline lattice, and
the adjustable stent lattice of the circular valve replacement
implant of FIG. 82;
FIG. 88 is an installation-side perspective view of another
exemplary embodiment of an actively controllable, petal-side
installed, circular valve replacement implant with an implant
skirt, opposing-side wall-retaining petals, and an internal valve
trampoline facing the implant skirt;
FIG. 89 is an installation-side perspective view of an implant
skirt frame, wall-retaining petals, a valve trampoline lattice, and
an adjustable stent lattice of the circular valve replacement
implant of FIG. 88;
FIG. 90 is a substantially side elevational view of the circular
valve replacement implant of FIG. 88;
FIG. 91 is a substantially side elevational view of the implant
skirt frame, the wall-retaining petals, the valve trampoline
lattice, and the adjustable stent lattice of the circular valve
replacement implant of FIG. 88;
FIG. 92 is a nosecone-side perspective view of the circular valve
replacement implant of FIG. 88;
FIG. 93 is a nosecone-side perspective view of the implant skirt
frame, the wall-retaining petals, the valve trampoline lattice, and
the adjustable stent lattice of the circular valve replacement
implant of FIG. 88;
FIG. 94 is a nosecone-side perspective view of another exemplary
embodiment of an actively controllable, circular valve replacement
implant;
FIG. 95 is an installation-side perspective view of the circular
valve replacement implant of FIG. 94;
FIG. 96 is a nosecone-side perspective view of another exemplary
embodiment of an actively controllable, circular valve replacement
implant with a trampoline valve;
FIG. 97 is an installation-side perspective view of the circular
valve replacement implant of FIG. 96;
FIG. 98 is an installation-side perspective view of an adjustable
stent lattice and valve trampoline lattice of the circular valve
replacement implant of FIG. 96;
FIG. 99 is a nosecone-side perspective view of the adjustable stent
lattice the and valve trampoline lattice of FIG. 98;
FIG. 100 is a nosecone-side perspective view of another exemplary
embodiment of an actively controllable, circular valve replacement
implant with an installation-side implant skirt;
FIG. 101 is an installation-side perspective view of the circular
valve replacement implant of FIG. 100;
FIG. 102 is a side perspective view of an adjustable stent lattice
and an implant skirt frame of the circular valve replacement
implant of FIG. 100;
FIG. 103 is a nosecone-side perspective view of another exemplary
embodiment of an actively controllable, circular valve replacement
implant with an installation-side implant skirt and a trampoline
valve; and
FIG. 104 is an installation-side perspective view of the circular
valve replacement implant of FIG. 103.
DETAILED DESCRIPTION OF THE INVENTION
As required, detailed embodiments of the systems, apparatuses, and
methods are disclosed herein; however, it is to be understood that
the disclosed embodiments are merely exemplary of the systems,
apparatuses, and methods, which can be embodied in various forms.
Therefore, specific structural and functional details disclosed
herein are optional and not to be interpreted as limiting, but
merely as a basis for the claims and as a representative basis for
teaching one skilled in the art to variously employ the systems,
apparatuses, and methods in virtually any appropriately detailed
structure. Further, the terms and phrases used herein are not
intended to be limiting; but rather, to provide an understandable
description of the systems, apparatuses, and methods. While the
specification concludes with claims defining the features of the
systems, apparatuses, and methods that are regarded as novel, it is
believed that the systems, apparatuses, and methods will be better
understood from a consideration of the following description in
conjunction with the drawing figures, in which like reference
numerals are carried forward.
In the following detailed description, reference is made to the
accompanying drawings which form a part hereof, and in which are
shown by way of illustration embodiments that may be practiced. It
is to be understood that other embodiments may be utilized and
structural or logical changes may be made without departing from
the scope. Therefore, the following detailed description is not to
be taken in a limiting sense, and the scope of embodiments is
defined by the appended claims and their equivalents.
Alternate embodiments may be devised without departing from the
spirit or the scope of the invention. Additionally, well-known
elements of exemplary embodiments of the systems, apparatuses, and
methods will not be described in detail or will be omitted so as
not to obscure the relevant details of the systems, apparatuses,
and methods.
Before the systems, apparatuses, and methods are disclosed and
described, it is to be understood that the terminology used herein
is for the purpose of describing particular embodiments only and is
not intended to be limiting. The terms "comprises," "comprising,"
or any other variation thereof are intended to cover a
non-exclusive inclusion, such that a process, method, article, or
apparatus that comprises a list of elements does not include only
those elements but may include other elements not expressly listed
or inherent to such process, method, article, or apparatus. An
element proceeded by "comprises . . . a" does not, without more
constraints, preclude the existence of additional identical
elements in the process, method, article, or apparatus that
comprises the element. The terms "including" and/or "having," as
used herein, are defined as comprising (i.e., open language). The
terms "a" or "an", as used herein, are defined as one or more than
one. The term "plurality," as used herein, is defined as two or
more than two. The term "another," as used herein, is defined as at
least a second or more. The description may use the terms
"embodiment" or "embodiments," which may each refer to one or more
of the same or different embodiments.
The terms "coupled" and "connected," along with their derivatives,
may be used. It should be understood that these terms are not
intended as synonyms for each other. Rather, in particular
embodiments, "connected" may be used to indicate that two or more
elements are in direct physical or electrical contact with each
other. "Coupled" may mean that two or more elements are in direct
physical or electrical contact (e.g., directly coupled). However,
"coupled" may also mean that two or more elements are not in direct
contact with each other, but yet still cooperate or interact with
each other (e.g., indirectly coupled).
For the purposes of the description, a phrase in the form "A/B" or
in the form "A and/or B" or in the form "at least one of A and B"
means (A), (B), or (A and B), where A and B are variables
indicating a particular object or attribute. When used, this phrase
is intended to and is hereby defined as a choice of A or B or both
A and B, which is similar to the phrase "and/or". Where more than
two variables are present in such a phrase, this phrase is hereby
defined as including only one of the variables, any one of the
variables, any combination of any of the variables, and all of the
variables, for example, a phrase in the form "at least one of A, B,
and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A,
B and C).
Relational terms such as first and second, top and bottom, and the
like may be used solely to distinguish one entity or action from
another entity or action without necessarily requiring or implying
any actual such relationship or order between such entities or
actions. The description may use perspective-based descriptions
such as up/down, back/front, top/bottom, and proximal/distal. Such
descriptions are merely used to facilitate the discussion and are
not intended to restrict the application of disclosed embodiments.
Various operations may be described as multiple discrete operations
in tum, in a manner that may be helpful in understanding
embodiments; however, the order of description should not be
construed to imply that these operations are order dependent.
Herein the relational terms "proximal" and "distal" are used.
Meanings for these terms are to be determined in the context in
which they are used. In various embodiments, where proximal and
distal are used with regard to the delivery system and the implant
to be deployed, the term "proximal" is in the direction towards the
delivery handle and the user and away from the implant and term
"distal" is in the direction away from the delivery handle and the
user and towards the implant.
As used herein, the term "about" or "approximately" applies to all
numeric values, whether or not explicitly indicated. These terms
generally refer to a range of numbers that one of skill in the art
would consider equivalent to the recited values (i.e., having the
same function or result). In many instances these terms may include
numbers that are rounded to the nearest significant figure. As used
herein, the terms "substantial" and "substantially" means, when
comparing various parts to one another, that the parts being
compared are equal to or are so close enough in dimension that one
skill in the art would consider the same. Substantial and
substantially, as used herein, are not limited to a single
dimension and specifically include a range of values for those
parts being compared. The range of values, both above and below
(e.g., "+/-" or greater/lesser or larger/smaller), includes a
variance that one skilled in the art would know to be a reasonable
tolerance for the parts mentioned.
It will be appreciated that embodiments of the systems,
apparatuses, and methods described herein may be comprised of one
or more conventional processors and unique stored program
instructions that control the one or more processors to implement,
in conjunction with certain non-processor circuits and other
elements, some, most, or all of the functions of the devices and
methods described herein. The non-processor circuits may include,
but are not limited to, signal drivers, clock circuits, power
source circuits, and user input and output elements. Alternatively,
some or all functions could be implemented by a state machine that
has no stored program instructions, or in one or more application
specific integrated circuits (ASICs) or field-programmable gate
arrays (FPGA), in which each function or some combinations of
certain of the functions are implemented as custom logic. Of
course, a combination of these approaches could also be used. Thus,
methods and means for these functions have been described
herein.
The terms "program," "software," "software application," and the
like as used herein, are defined as a sequence of instructions
designed for execution on a computer system or programmable device.
A "program," "software," "application," "computer program," or
"software application" may include a subroutine, a function, a
procedure, an object method, an object implementation, an
executable application, an applet, a servlet, a source code, an
object code, any computer language logic, a shared library/dynamic
load library and/or other sequence of instructions designed for
execution on a computer system.
Herein various embodiments of the systems, apparatuses, and methods
are described. In many of the different embodiments, features are
similar Therefore, to avoid redundancy, repetitive description of
these similar features may not be made in some circumstances. It
shall be understood, however, that description of a first-appearing
feature applies to the later described similar feature and each
respective description, therefore, is to be incorporated therein
without such repetition.
Described now are exemplary embodiments of the present invention.
Referring now to the figures of the drawings in detail and first,
particularly to FIGS. 1 to 13, there is shown a first exemplary
embodiment of an actively controllable delivery and deployment
system 100, for example, for an actively controllable mitral heart
valve replacement implant 200. The delivery system 100 includes an
inner elongate member that comprises a guidewire lumen 110, a
nosecone 120 disposed at the distal end of the guidewire lumen 110,
a hollow exterior sheath 130 surrounding the guidewire lumen 110
and shaped to smoothly connect to the proximal end of the nosecone
120, and a non-illustrated delivery and deployment handle connected
to the guidewire lumen 110, to the exterior sheath 130, and to
implant controls that are described in further detail below. The
sheath-nosecone connection is established by forming the proximal
end of the nosecone 120 with a taper 122 that ends with an abutting
wall 124 at the proximal most end of the distal nosecone taper 126.
The distal taper 126 has an outer diameter at the wall 124 that is
substantially equal to the outer diameter of the distal end of the
sheath 130 and the wall 124 has a height that is substantially
equal to the thickness of the material of the hollow sheath
130.
The actively controllable mitral heart valve replacement implant
200 is, in FIG. 1, compressed within the sheath 130 and surrounding
the guidewire lumen 110, as can be seen in FIG. 2, in which the
sheath 130 has been retracted proximally to such an extent that the
implant 200 can be seen in its entire longitudinal extent. Even
though the implant 200 should be expanded further than the
configuration shown in FIG. 2 when it is fully exposed from the
sheath 130, the implant 200 is depicted in FIG. 2 in only a
slightly expanded orientation as compared to the completely encased
and compressed orientation of the non-visible implant 200 in FIG.
1.
The implant 200 has an external, adjustable stent lattice 210. The
stent lattice 210 can be of a shape memory material (such as
nitinol, for example). The adjustable stent lattice 210 is set to a
pre-determined shape that, in this exemplary mitral valve
embodiment, is D-shaped as shown in FIG. 5 and, particularly, in
FIGS. 9 to 12. (In an alternative exemplary embodiment where the
implant site is circular, the adjustable stent lattice would be
pre-set to a circular shape.) Connected to the interior of the
adjustable stent lattice 210 is a self-expanding valve trampoline
lattice 230. The trampoline lattice 230 can be integral with the
adjustable stent lattice 210 or fixedly connected thereto, for
example, by crimping, banding, welding. A set of hollow disconnect
lumens 140 surround lattice drive wires 150 and both are
operatively connected to a non-illustrated delivery and deployment
handle (also referred to as a controller because it need not be
shaped as a handle). The exemplary embodiment of the disconnect
lumens 140 are tubes that extend from the handle to the implant 200
and each surround a drive wire 150. Lattice disconnect tubes 142
are respectively disposed at the end of each hollow disconnect
lumens 140. The lattice disconnect tubes 142 are rotationally fixed
to the disconnect lumens 140 such that, when the disconnect lumen
140 rotates, the respective lattice disconnect tube 142 rotates
correspondingly. The lattice disconnect tubes 142 surround the
distal end of the drive wires 150, at which distal end are drive
wire connectors 152. The drive wire connectors 152 are each shaped
to connect to respective proximal ends of jack screws 220 that are
rotatably connected to the adjustable stent lattice 210 as
described in further detail below.
FIG. 2 depicts the implant 200 without an implant skirt and a valve
trampoline (which are removed for clarity but are shown in FIG. 4).
The implant 200 is in a pre-installation orientation before the
drive wires 150 have caused the jack screws 220 to expand the
adjustable stent lattice 210. The lattice disconnect tubes 142 at
each distal end of the disconnect lumens 140 are partially visible
from under the outer sheath 130. Under the lattice disconnect tubes
142, the drive wires 150 are removably connected to the proximal
end of each jack screw 220 so that, as long as the lattice
disconnect tubes 142 remain in this distally disposed state
adjacent the proximal end of the adjustable stent lattice 210, the
drive wires 150 are rotationally fixed to the proximal end of each
jack screw 220, which means that, as a drive wire 150 rotates, the
respective jack screw 220 rotates correspondingly. The
non-illustrated delivery and deployment handle controls expansion
and contraction of the adjustable stent lattice 210 and deployment
of the implant 200 by rotation of the drive wires 150 and, when
deployment is desired, by proximal movement of the disconnect
lumens 140, which, when moved proximally, translate the lattice
disconnect tubes 142 away from the connection between the drive
wires 150 and the expansion/contraction assembly of the adjustable
stent lattice 210 (see jack screws below) to permit automatic
separation of the drive wires 150 and the jack screws.
The self-expanding valve trampoline lattice 230 is disposed within
a central orifice of the adjustable stent lattice 210 and is
attached to the adjustable stent lattice 210. FIG. 3 shows the
sheath 130 entirely removed from the implant 200 and the lattice
disconnect tubes 142. Here, the adjustable stent lattice 210 is
further expanded towards its pre-defined self-expanding shape.
Visible in FIG. 3 is the connection location of the drive wire
connectors 152 and the proximal end of the jack screws 220, but
that connection is hidden within the respective lattice disconnect
tubes 142.
FIG. 4 illustrates the implant 200 in approximately its fully
self-expanded state. The exterior implant skirt 240 and the valve
trampoline lattice 230 are shown but are transparent in this
figure. As will be explained in further detail below, the implant
skirt 240 is attached (e.g., with sutures in the shape of an "X")
to the exterior surfaces of the adjustable stent lattice 210.
FIG. 5 illustrates the implant 200 in a partially forcibly expanded
state and FIG. 6 illustrates the implant 200 in a further expanded
state. The implant 200 is rotated in FIG. 6 to show more of the
left ventricle side of the implant, i.e., the side of the implant
configured to be positioned with the left ventricle of the patient.
Here, the exterior implant skirt 240 and the valve trampoline
lattice 230 are fully resolved and, therefore, the implant skirt
240 covers the adjustable stent lattice 210 so that it is no longer
visible. The self-expanding, memory shaped skirt lattice 242 is
visible beneath the exterior material 244 of the implant skirt 240
for clarity. The material 244 can be made from anything that is
fluid-tight or resistant and retains that fluid-tight or resistant
characteristic even after being attached to the skirt lattice 242
or to the adjustable stent lattice 210 with sutures that puncture
the material 244, for example. The material 244 can be a woven
polyester fabric, a sheet of plastic, and/or a sheet of pericardial
tissue, for example. Preferably, the material 244 is of braided
polyester coated with polyurethane. As can be seen on the exterior
surface of the material 244, sutures 246 (e.g., in the shape of an
"X") fixedly attach the material 244 and the skirt lattice 242 to
the adjustable stent lattice 210 therein such that, as the
adjustable stent lattice 210 expands, both the skirt lattice 242
and the material 244 expands correspondingly, as is shown, for
example, in the transition from FIG. 5 to FIG. 6.
Extending proximally from skirt lattice 242 (and being part of the
skirt lattice 242) are left-atrium wall-retaining petals 248. Even
though the material 244 prevents viewing of the entire extent of
the retaining petals 248, it can be seen in FIGS. 5 and 6 that the
lattice disconnect tubes 142 are disposed radially outside the
retaining petals 248 but inside the skirt lattice 242/material 244.
In this manner, the petals 248 are prevented from expanding
radially outwards until the lattice disconnect tubes 142 are
disconnected from the adjustable stent lattice 210. FIG. 6 shows
the implant 200 in an exemplary fully-expanded, delivery
orientation with the drive wires 150 still engaged to the implant
200. It is noted that the circular shape of the retaining petals
248 is only one exemplary configuration for retaining the implant
200 on the atrium side of the mitral valve annulus. These petals
248 can take any shape that, after being allowed to pivot in a
direction from the guidewire lumen 110 radially outward, allows the
implant 200 to be secured on the atrium side.
When the implant 200 is positioned in a final desired orientation,
such as that shown in FIGS. 7 through 13, the drive wires 150 are
to be disconnected from all of the jack screws 220 and, thereafter,
removed from the patient. To disengage the drive wires 150, a
non-illustrated control handle moves each of the disconnect lumens
140 proximally (either simultaneously or separately) to thereby
slide the hollow disconnect tubes 142 away from the adjustable
stent lattice 210. When this covering is removed, the temporary
connection of the drive wire connectors 152 and the proximal ends
of the jack screws 220 can be allowed to separate from one another,
as shown in FIG. 7, allowing the disconnect lumens 140 and the
drive wires 150 (and the sheath 130 if desired) to retract away
from the adjustable stent lattice 210. The collapsed or contracted
state of the wall-retaining petals 248 only remains while the
disconnect lumens 140 and the drive wires 150 remain connected to
the adjustable stent lattice 210. When disconnected therefrom, the
petals 248 are allowed to move to their steady state or pre-set
orientation, which is a position where the petals 248 extend in a
plane that is substantially perpendicular to the axis of the
guidewire lumen 110. Likewise, when allowed to self-expand, the
skirt lattice 242 moves to its steady-state or pre-set orientation,
which is a position where the edges of the skirt lattice 242 extend
in a plane that is more perpendicular to the axis of the guidewire
lumen 110 than parallel thereto. This orientation of the implant
200 secured in a target location, such as the mitral valve annulus,
is depicted in the views of FIGS. 9 to 12 and, in particular, in
the side elevational view of FIG. 13. As can be seen in FIG. 13,
the angle .alpha. between the petals 248 and the central axis 202
of the implant 200 is between approximately 45 degrees and
approximately 90 degrees including every number therebetween. In
particular, the angle .alpha. is between approximately 50 degrees
and approximately 75 degrees including every number
therebetween.
Also shown in FIGS. 5 to 13 is the structure of the valve
trampoline lattice 230, including a centrally disposed valve 250,
which, in this exemplary embodiment, is a replacement for a mitral
valve. More particularly, as shown in FIG. 5, the self-expanding
valve trampoline lattice 230 has an expandable outer trampoline
portion 232 and an expandable but fixed maximum diameter inner
circumferential valve portion 234, which can be cylindrical and,
for example, fabricated from a laser-cut, nitinol tube. The outer
trampoline portion 232 connects on its exterior circumference to an
interior circumference of the adjustable stent lattice 210. The
connection can be integral or can be formed, for example, by
crimping, banding, and/or welding. Deformable cells of the outer
trampoline portion 232 allow the outer trampoline portion 232 to
expand and contract substantially. In this example, the cells are
substantially marquis-shaped or tear-drop shaped, but they can take
other closed curved or straight shapes. More particularly in the
exemplary embodiment of FIGS. 5 to 13, the valve trampoline lattice
230 has figure-eight-shaped structures that, when attached together
at their sides, form five rows of cells that circumscribe the valve
trampoline lattice. The outer trampoline portion 232 includes the
first four rows of tear-drop and marquis-shaped cells. A first row
of relatively smaller tear-drop-shaped cells 232a (see FIGS. 7 and
8) are sixteen in number and define an outermost ring of outer
trampoline portion 232 cells. A second row of relatively larger
marquis-shaped cells 232b, also sixteen in number, define a first
inner ring of the outer trampoline portion 232. A third row of
sixteen marquis-shaped cells 232c narrower and longer than the
cells 232b define a second inner ring of the outer trampoline
portion 232. Finally, a fourth row of sixteen smallest
marquis-shaped cells 232d define a third inner ring of the outer
trampoline portion 232. In comparison, the inner circumferential
valve portion 234 of the valve trampoline lattice 230 has one row
of sixteen cells 234a about its circumference, each cell having a
longitudinal length that is about the same as the circumferential
width. Accordingly, these sixteen cells 234a are substantially
circular, even though they have tear-drop tips on either end. The
substantially circular nature of the sixteen cells 234a creates a
cylinder at the interior end of the valve trampoline lattice 230.
This compound structure allows the inner circumferential valve
portion 234 to remain substantially circular even while the outer
trampoline portion 232 expands and contracts with expansion or
contraction of the adjustable stent lattice 210.
Accordingly, when the adjustable stent lattice 210 expands or
contracts, the outer circumference of the outer trampoline portion
232 correspondingly expands or contracts without limitation. The
inner circumferential valve portion 234 connects to the outer
trampoline portion 232 at cell connection points 233. This inner
circumferential valve portion 234 is not D-shaped and does not have
cells that allow it to expand and contract in the same way that the
cells of the outer trampoline portion 232 permit unrestricted
expansion. Instead, in this exemplary configuration, the cells of
the inner circumferential valve portion 234 only allow expansion up
to a pre-determined state once the adjustable stent lattice 210 is
expanded far enough to no longer constrain the inner
circumferential valve portion 234. At that state, which is shown
starting at FIG. 6, the cells forming the outer circumference of
the inner circumferential valve portion 234 are disposed about the
central axis 202 of the implant 200 in a substantially circular
manner defining a pre-determined maximum diameter D, shown in FIGS.
7 and 8 and continues in FIGS. 9 to 13. Thus, no matter how far the
adjustable stent lattice 210 expands the outer trampoline portion
232 of the trampoline lattice 230, the inner circumferential valve
portion 234 will not expand past the diameter D.
The reason why the trampoline lattice 230 is referred to as a
"trampoline" is because of the way that it supports the valve 250.
At the inner circumferential valve portion 234, the trampoline
lattice 230 is substantially constant after the adjustable stent
lattice 210 has expanded to no longer restrict the inner
circumferential valve portion 234. The outer trampoline portion
232, in contrast, expands to whatever shape is needed to bridge the
gap between the inner circumferential valve portion 234 and the
adjustable stent lattice 210. Thus, the outer portion 232 acts as a
stretchable "trampoline" to move and adjust to whatever shape is
needed to suspend the relatively stable inner circumferential valve
portion 234 (and the valve 250) at the central region of the
trampoline lattice 230. The natural shape of the outer trampoline
portion 232 corresponds to the inner circumference of the
adjustable stent lattice 210, which means it has a natural D-shaped
circumference.
Both the outer trampoline portion 232 and the inner circumferential
valve portion 234 are fluid-tightly sealed to the material 244 so
that, when installed, the implant 200 forms a fluid-tight seal that
only permits fluid flow through the valve 250. As shown best in
FIGS. 9 and 10, a first sealing material 235 is secured to the
inside surfaces of the outer trampoline portion 232 and a second
sealing valve material 237 is secured to the inside surfaces of the
inner circumferential valve portion 234. The second sealing valve
material 237 can be a single sheet with three leaflets cut therein
or it can be a set of three separate leaflet portions individually
connected to the interior surfaces of the inner circumferential
valve portion 234. The material 235 can be a woven polyester
fabric, a sheet of plastic, and/or a sheet of pericardial tissue,
for example. The material 237 can be pericardial tissue or a
natural valve harvested from a mammal, such as a porcine valve. In
this exemplary embodiment, the second sealing valve material 237
extends from the distal most ends of the inner circumferential
valve portion 234 to the center of the valve 250 and, thereby,
forms the leaflets 252 of the valve 250, which, in this embodiment,
is a tricuspid form (i.e., three leaflets 252). The tricuspid form
is not to be considered as limiting and can have any number of
leaflets. The first sealing material 235 and the second sealing
valve material 237 can be separate, with the leaflets 252 extending
into the central orifice of the inner circumferential valve portion
234 from either the first or second materials 235, 237, or they can
be integral, with the leaflets 252 being a part of the material
portions 235, 237 and extending into the central orifice of the
inner circumferential valve portion 234.
With the petals 248 on the atrium side of the now-installed implant
200 and the skirt lattice 242 with its material 244 on the
ventricle side of the implant 200, the diseased mitral valve
annulus is captured and surrounded by the implant 200 in a
liquid-tight and leak-free manner. Viewed in a cross-sectional
plane extending along the axis of the guidewire lumen 110,
therefore, the petals 248 and the skirts lattice 242 with the
material 244 forms a U-shaped annular raceway as depicted in FIG.
13.
This capture of the native mitral valve annulus is depicted in the
progression of FIGS. 14 to 22, which is an example of replacement
mitral valve implantation with a transapical approach. In FIG. 14,
a guidewire 10 has been installed through the atrium wall and the
diseased mitral valve 12 and rests in the left ventricle. The
guidewire lumen 110 is threaded onto the guidewire 10 and the
guidewire lumen 110 enters the left atrium preceded by the distally
connected nosecone 120. The nosecone 120 of the delivery system 100
is extended into the left ventricle in FIG. 15. In FIG. 16, the
outer sheath 130 has been withdrawn into the left atrium and the
mitral valve replacement implant 200 contained within the sheath
130 starts to be exposed within the diseased mitral valve annulus.
In FIG. 17, the outer sheath 130 has been withdrawn almost all of
the way over the mitral valve replacement implant 200 to an extent
where the implant skirt 240 is able to self-expand into and towards
the sub-valvular structures below the diseased mitral valve
annulus. In FIG. 18, the outer sheath 130 has been withdrawn
completely from the mitral valve replacement implant 200 to an
extent where the sheath 130 only constrains the disconnect lumens
140 and drive wires 150. The implant skirt 240 is further
self-expanded into the sub-valvular structures below the diseased
mitral valve annulus. In FIG. 19, the outer sheath 130 has been
withdrawn completely to no longer radially constrain the disconnect
lumens 140 or drive wires 150 to, thereby, allow the adjustable
stent lattice 210 to self-expand to its pre-determined, memory
shape. The implant skirt 240 is further self-expanded into and
touching the sub-valvular structures below the diseased mitral
valve annulus to an extent that it could reach and touch the chords
beyond the native leaflet edges if sized appropriately. FIG. 20
shows the adjustable stent lattice 210 forcibly expanded radially
outwards and the implant skirt 240 remaining secured against the
sub-valvular structures below the diseased mitral valve annulus but
also adapting to the forcibly expanded orientation of the internal
adjustable stent lattice 210. Finally, FIG. 21 illustrates the
mitral valve replacement implant 200 in a fully expanded and
implanted orientation within the mitral valve annulus just before
disconnection of the drive wires 150. As can be seen, the implant
skirt 240 substantially engages the native leaflets 14 and chordae
tendineae 16 to create a fluid tight seal at the mitral valve
annulus.
The process for installing the implant 240 from the atrial side is
shown in the progression of FIGS. 22 through 35. FIGS. 22 and 23
illustrate the guidewire 10 resting in the left ventricle
(installed through the atrium wall) and the diseased mitral valve
12. The guidewire lumen 110 is threaded onto the guidewire 10 and
enters the left atrium preceded by the distally connected nosecone
120, resting in the left ventricle. The mitral valve 12 is shown
partially closed in FIG. 22 and substantially open in FIG. 23. The
implant 200 is compressed within the exterior sheath 130 but the
sheath 130 is not illustrated for clarity. In FIG. 24, the outer
sheath 130 has been retracted to allow the implant 240 to start
self-expanding to its pre-defined, mitral valve D-shape and the
implant skirt 240 to start self-expanding within the ventricle to
its pre-defined memory shape. In this figure, the mitral valve 12
is substantially open. The adjustable stent lattice 210 is
positioned within the mitral valve annulus, as can be seen in FIG.
25, where the mitral valve 12 is closed upon the adjustable stent
lattice 210. As the drive wires 150 and disconnect lumens 140 are
still connected to the adjustable stent lattice 210, the atrium
wall-retaining petals 248 are constrained at the interior sides of
the disconnect lumens 140. With the implant 200 centrally disposed
within the mitral valve 12, the drive wires 150 can be rotated to
actuate the jack screws 220 and, thereby, start expansion of the
implant 200. FIG. 26 shows the implant 200 in the state where the
implant 200 is fully self-expanded and defines the pre-defined
D-shape of the implant (albeit smaller than when implanted), and
FIG. 27 shows the implant 200 in a first, forcibly expanded state,
with the D-shape larger than the pre-set D-shape. With the mitral
valve 12 partially open around the implant 200, the implant skirt
240 can be seen on the ventricle side self-expanded to such an
extent that it already occludes the opening of the mitral valve 12,
which is due both to the self-expanding features of the implant
skirt 240, 242, 244 and to the pressure exerted on the ventricle
side of the implant skirt 240 by blood flow. Likewise, this blood
flow imparts a force on the replacement valve 250, causing the
leaflets 252 to open and allow blood flow through the implant 200.
With still further expansion of the implant 200, as shown in FIGS.
28 and 29, expansion of the outer trampoline portion 232 becomes
more apparent and the replacement valve 250 begins to function as a
valve well before full implantation occurs. This valve functioning
is clearly shown in FIGS. 30 and 31, in which, a further expanded
state of the implant 200 allows the leaflets 252 of the replacement
valve 250 to fully open and fully close (about the guidewire lumen
110).
When the implant 200 has been expanded to a state where it is fixed
in the diseased mitral valve 12 to hold the diseased mitral valve
12 open, as shown in FIG. 32, the implant 200 is ready to be
disengaged from the delivery system 100. At this point, the surgeon
can ensure correct implantation because the implant 200 has the
ability to reversibly contract and be repositioned if desired. To
confirm that the implant 200 is in a desired final state, the
surgeon can inject a contrast dye into the ventricle (e.g., through
the guidewire lumen 110 or through the guidewire 10, if either is
configured to deliver dye, or through a separate contrast device
within the ventricle). When the surgeon has determined that no
leakage occurs around the implant 200 and that the implant 200 is
satisfactorily installed, the surgeon can actuate the disengagement
feature of the delivery system 100, which, in this exemplary
embodiment, causes the disconnect lumens 140 to retract proximally
and, thereby, move the lattice disconnect tubes 142 away from the
drive wire connectors 152. FIG. 33 illustrates the disconnect
lumens 140 having retracted the lattice disconnect tubes 142 from
the drive wires 150 to expose the drive wire connectors 152 (which
engage the proximal ends of the jack screws 220 and remain engaged
only so long as the lattice disconnect tubes 142 are extended) and,
thereby, allow the drive wire connectors 152 to disengage
automatically from the jack screws 220. At this point, implantation
is final and cannot be reversed without physically removing the
implant 200, e.g., through a secondary open surgical procedure.
However, such a situation is not necessary when the surgeon has
ensured correct placement before disengagement.
Now that the disconnect lumens 140 and lattice disconnect tubes 142
no longer restrain the atrium wall-retaining petals 248, the petals
248 can expand outward to their pre-set orientation. FIG. 33 shows
the petals 248 in the process of this expansion and FIG. 34
illustrates the petals 248 fully expanded and compressing the
ventricle side of the mitral valve 12 in a direction of the implant
skirt 240, which, itself, is fully expanded and imparting a
compressive force against the atrium side of the mitral valve 12.
As the implant process is complete, the disconnect lumens 140 and
the drive wires 150 can be removed, which is depicted in FIG.
35.
Above, the implant skirt 240 is described as self-expanding on the
ventricle side of the mitral valve 12 starting from the time that
it is released from capture within the exterior sheath 130. That
expansion is shown from a side of the implant 240 in FIGS. 18
through 21, 24, and 27. FIGS. 36 through 43, however, show the
behavior of the implant skirt 240 as the adjustable stent lattice
210 is forcibly expanded from its fully self-expanded state (shown
in FIG. 36) until the time of final implantation (shown in FIG.
40). FIGS. 36 through 43 show this behavior viewed from the
ventricle side of the implant 200. As the adjustable stent lattice
210 forcibly expands from its self-expanded state in FIG. 36
through the range of expansion in FIGS. 37, 38, and 39, it can be
seen that the innermost portions of the implant skirt 240,
including the skirt lattice 242 and the outer material 244, move
and adjust to accommodate the ever-expanding outer extremities of
the outer trampoline portion 232. In contrast, the outermost
annulus of the implant skirt 240 remains substantially constant
from the time that it is completely released from the sheath 130
until the time when the implant 200 is in its final implant
orientation, which is seen in FIG. 40. At this point, the stent
control devices (disconnect lumens 140 and drive wires 150) can be
disconnected and withdrawn, which is depicted in FIG. 40, these
devices 140, 150 being entirely removed from view in FIG. 41 and
the nosecone 120 being withdrawn in the progression of FIG. 42 to
FIG. 43. These figures illustrated that the replacement valve 250
has functioning leaflets 252 from the time that the adjustable
stent lattice 210 is merely allowed to self-expand and continues
functioning as a valve all during the time that the implant 200 is
being adjusted, expanded, contracted, moved, and/or rotated. These
figures also show how the valve trampoline lattice acts as a
trampoline. The inner circumferential valve portion 234 remains
patent in its circular orientation throughout the time that the
outer trampoline portion 232 is being expanded (or contracted).
FIGS. 44 to 47 illustrate an alternative embodiment of an actively
controllable stent graft 300. This implant is similar in structure
to the implant 200 except the wall-retaining petals 248 and the
exterior implant skirt 240 are not present. Although the interior
valve assembly also is not present, any valve assembly can be
included within the adjustable stent lattice 310 of the implant
300. The implant 300 can be substantially circular or it can be
D-shaped. As all other aspects of the implant 300 are similar to
the implant 200, all features are not repeated to avoid unnecessary
repetition. Likewise, where similar parts are referenced, the
reference numeral is increased by 100. What is different with the
implant 300 is that the tissue-fixation structures are extendible
hooks 342 that are part of or attached to the adjustable stent
lattice 310. Such hooks 342 can take the form of the needles 1700
or 2200 or 3070 shown and described in U.S. Patent Publication No.
2013/0046373 to Cartledge et al.
Deployment of the implant 300 is performed just as implant 200. The
delivery system 100 in FIG. 44 is guided along a non-illustrated
guidewire to an implant site in the patient. The adjustable stent
lattice 310 is allowed to self-expand after removal of the sheath
130 and then is forcibly expanded into the annulus of the implant
site to a final implant size, the implant 300 being reversibly
expanded and contracted as desired to achieve optimal deployment.
This expansion is shown in FIGS. 45 and 46 (the graft material 335
of the implant 300 is not illustrated in FIG. 45). When the implant
300 is in the desired location and orientation and is ready to be
released, the extendible hooks 342 are extended out from the sides
of the implant 300 to enter into and fixedly connect to the tissue
at the implant site. Only three of the hooks 342 are illustrated in
FIG. 47 but this number is not to be limiting. In an exemplary
embodiment, the number of hooks 342 is equal to the number of
disconnect lumens 140, which in the embodiment shown would be six
in number.
FIGS. 48 to 52 illustrate the process for deploying the implant
300, for example, in the mitral valve of a heart. In contrast to
the embodiment of implant 200, which is inserted through the atrium
from above the heart, the implant 300 is inserted through a
transapical approach. The delivery system 100 is inserted through
the apex of the heart up through the left ventricle and through the
mitral valve 12 to place the nosecone 120 within the left atrium.
The implant 300 is expanded into the mitral valve 12 as shown in
FIGS. 49 and 50. When ready to implant, the hooks 342 are extended
into the wall of the heart. In FIG. 52, the implant 300 is released
from the delivery system 100 and the internal valve leaflets
function to valve the blood flow.
FIGS. 53 to 57 illustrate an alternative embodiment of an actively
controllable replacement mitral valve implant 400. This implant is
similar in structure to the implant 200 except the wall-retaining
petals 248 are not present Like implant 200, the implant 400 has an
exterior implant skirt 440. The implant 400 can be substantially
circular, but it is D-shaped in this mitral valve embodiment. As
all other aspects of the implant 400 are similar to the implant
200, all features are not repeated to avoid unnecessary repetition.
Likewise, where similar parts are referenced, the reference numeral
is increased by 200. What is different with the implant 400 is that
the implant skirt 440 is supplemented with tissue-fixation
structures in the form of extendible hooks 442 that are part of or
attached to the adjustable stent lattice 410. Such hooks 442 can
take the form of the needles 1700 or 2200 or 3070 shown and
described in U.S. Patent Publication No. 2013/0046373 to Cartledge
et al.
Deployment of the implant 400 is performed just as implant 200. The
delivery system 100 in FIG. 53 is guided along a non-illustrated
guidewire to an implant site in the patient. The adjustable stent
lattice 410 is allowed to self-expand after the sheath is removed
and then is forcibly expanded into the annulus of the mitral valve
to a final implant size, the implant 400 being reversibly expanded
and contracted as desired to achieve optimal deployment. As with
implant 200, when the sheath 130 is removed from the compressed
implant 400, the implant skirt 440 is allowed to self-expand on the
ventricle side of the mitral valve annulus. This expansion is shown
in FIGS. 54 and 55 (the graft material 435 of the implant 400 is
not illustrated in FIG. 54). When the implant 400 is in the desired
location and orientation and is ready to be released, the
extendible hooks 442 are extended out from the sides of the implant
400 to enter into and fixedly connect to the tissue at the implant
site. Only three of the hooks 442 are illustrated in FIG. 56 but
this number is not to be limiting. In an exemplary embodiment, the
number of hooks 442 is equal to the number of disconnect lumens
140, which in the embodiment shown would be six in number.
FIGS. 58 to 62 illustrate the process for deploying the implant 400
in the mitral valve annulus of a heart. In contrast to the
embodiment of implant 200, which is inserted through the atrium
from above the heart, the implant 400 is inserted through a
transapical approach. The delivery system 100 is inserted through
the apex of the heart up through the left ventricle and through the
mitral valve 12 to place the nosecone 120 within the left atrium.
The implant 400 is expanded into the mitral valve 12 as shown in
FIGS. 59 and 60. When ready to implant, the hooks 442 are extended
into the wall of the heart. In FIG. 62, the implant 400 is released
from the delivery system 100 and the internal valve leaflets 452
function to valve the blood flow.
FIGS. 63 to 67 illustrate an alternative embodiment of an actively
controllable replacement mitral valve implant 500. This implant is
similar in structure to the implant 200 except the wall-retaining
petals 248 are not present Like implant 200, the implant 500 has an
exterior implant skirt 540. The implant 500 can be substantially
circular, but it is D-shaped in this mitral valve embodiment. As
all other aspects of the implant 500 are similar to the implant
200, all features are not repeated to avoid unnecessary repetition.
Likewise, where similar parts are referenced, the reference numeral
is increased by 300. What is different with the implant 500 is that
the implant skirt 540 is supplemented with tissue-fixation
structures in the form of extendible hooks 542 that are part of or
attached to the adjustable stent lattice 410. The self-expanding
valve trampoline lattice 530 is also present. The hooks 542 can
take the form of the needles 1700 or 2200 or 3070 shown and
described in U.S. Patent Publication No. 2013/0046373 to Cartledge
et al.
Deployment of the implant 500 is performed just as implant 200. The
delivery system 100 in FIG. 63 is guided along a non-illustrated
guidewire to an implant site in the patient. The adjustable stent
lattice 510 is allowed to self-expand after the sheath is removed
and then is forcibly expanded into the annulus of the mitral valve
to a final implant size, the implant 500 being reversibly expanded
and contracted as desired to achieve optimal deployment. As with
implant 200, when the sheath 130 is removed from the compressed
implant 500, the implant skirt 540 is allowed to self-expand on the
ventricle side of the mitral valve annulus. This expansion is shown
in FIGS. 64 and 65 (the graft material 535 of the implant 500 is
not illustrated in FIG. 64). When the implant 600 is in the desired
location and orientation and is ready to be released, the
extendible hooks 542 are extended out from the sides of the implant
500 to enter into and fixedly connect to the tissue at the implant
site. Only three of the hooks 542 are illustrated in FIG. 66 but
this number is not to be limiting. In an exemplary embodiment, the
number of hooks 542 is equal to the number of disconnect lumens
140, which in the embodiment shown would be six in number.
FIGS. 68 to 72 illustrate the process for deploying the implant 500
in the mitral valve annulus of a heart. In contrast to the
embodiment of implant 200, which is inserted through the atrium
from above the heart, the implant 500 is inserted through a
transapical approach. The delivery system 100 is inserted through
the apex of the heart up through the left ventricle and through the
mitral valve 12 to place the nosecone 120 within the left atrium.
The implant 500 is expanded into the mitral valve 12 as shown in
FIGS. 69 and 70. When ready to implant, the hooks 542 are extended
into the wall of the heart. In FIG. 72, the implant 500 is released
from the delivery system 100 and the internal, non-illustrated
valve leaflets function to valve the blood flow.
FIG. 73 illustrates an exemplary embodiment of the implant 500,
viewed from the atrium side thereof with the expandable outer
trampoline portion 532 deployed and the leaflets 552 of the inner
circumferential valve portion 534 in an almost closed state. FIGS.
74 and 75 show the skeleton of the implant 500 with the outer
material and trampoline valve removed. The implant skirt 540
comprises two parts, an outer circumferential ring 541 and a set of
ring-connecting struts 543, which connect the ring 541 to the
adjustable stent lattice 510. Both the ring 541 and the struts 543
are made of a material that is self-expanding and having a desired,
pre-set shape (such as heat-set nitinol, for example). The struts
543 can be integral with the ring 541 and/or the adjustable stent
lattice 510 or connected thereto. The various parts of the
adjustable stent lattice 510 are best viewed in FIG. 75. The
adjustable stent lattice 510 comprises sets of jack screw
connectors, each set having a proximal jack strut 512 and a distal
jack strut 514. Arms 516 connect each of the proximal and distal
jack struts 512, 514 to an intermediate strut 518. Jack screws 520,
which are non-illustrated for clarity but one is depicted as a
dashed line in FIG. 75, connect to the proximal and distal jack
struts 512, 514 so that, when the jack screw 520 is turned in one
direction, the proximal and distal jack struts 512, 514 separate
from one another and, when the jack screw 520 is turned in the
other opposite direction, the proximal and distal jack struts 512,
514 move towards one another. This configuration can be achieved in
various ways. One exemplary embodiment fixes a non-illustrated
threaded nut within the distal jack strut 514 to allow the jack
screw 520 to threadedly enter into and retract from a smooth-bored
hollow in the distal jack strut 514 and places a rotationally free
but longitudinally fixed connection of the jack screw 520 at the
proximal jack strut 512. In this manner, when the jack screw 520 is
rotated in a strut-approaching direction, the distal end of the
jack screw 520 moves into the internal non-threaded bore of the
distal jack strut 514 (via the connection with threads of the nut)
and the proximal end of the jack screw 520 remains longitudinally
fixed at the proximal jack strut 512 but is allowed to rotate
freely therein. As set forth above, the proximal end of the jack
screw 520 has a connector part that is removably connected to a
drive wire connector 150 of a drive wire 150 so that, when the
drive wire connector 150 is caused to rotate, the jack screw 520
rotates correspondingly. This connection is maintained in any of
the exemplary embodiments when the lattice disconnect tubes
surround both the proximal end of the jack screw (referred to as a
driving connector) and the drive wire connector 150. One way to
form the removable connection is through a form fit, such as two
cylinders having a mirrored handshake keying that only remains
connected when a hollow cylindrical shroud encircles that
connection. A form-locking or form-fitting connection is one that
connects two elements together due to the shape of the elements
themselves, as opposed to a force-locking connection, which locks
the elements together by force external to the elements.
With such a configuration, rotation of the many jack screws 520 in
the strut-approaching direction causes the proximal and distal jack
struts 512, 514 to move towards one another and, thereby, push the
intermediate struts 518 (which are disposed parallel to the jack
screws 520) away from the jack screw 520 in a direction along the
circumferential extent of the annulus of the adjustable stent
lattice 510. This relative movement of the intermediate strut 518
and the jack screw assemblies causes expansion of the adjustable
stent lattice 510 when the proximal and distal jack struts 512, 514
move towards one another and causes contraction of the adjustable
stent lattice 510 when the proximal and distal jack struts 512, 514
move away from one another. Ideally, all of the jack screws 520 are
rotated at the same speed to but such equal movement is not to be
considered limiting.
In the exemplary embodiment of the adjustable stent lattice 510
shown, there are eight pairs of jack struts 512, 514 and eight
intermediate struts 518. This number is merely exemplary and there
can be, for example, only six of each or any other number desired
including any number from 1 to 10. Connecting the pairs of jack
struts 512, 514 and the intermediate struts 518 are the laterally
extending arms 516. As the adjustable stent lattice 510 is either
contracted or expanded, the arms 516 each flex at their two
endpoints, one at a respective intermediate strut 518 and the other
at a respective one of a pair of jack struts 512, 514. As can be
seen from the configuration shown in FIG. 75, when the adjustable
stent lattice 510 is contracted (e.g., for installation into the
delivery sheath 130), the arms 516 move towards a longitudinal
orientation (parallel to the jack screws and to the central axis of
the lattice 510. Conversely, when the adjustable stent lattice 510
is expanded (e.g., for implantation), the arms 516 angle away from
the respective intermediate strut 518 and one of the pair of jack
struts 512, 514 in a circumferential orientation (perpendicular to
the jack screws).
While this detailed description of the parts of the adjustable
stent lattice 510 is present herein with respect to implant 500, it
is equally applicable to the each of the alternative implant
embodiments described herein.
As stated above, the structures forming the various exemplary
embodiments for heart valves are not limited to only a single valve
or a single exterior shape. The features can be extended to
alternative configurations.
A first alternative configuration of a mitral valve replacement
implant 600 is shown in FIGS. 78 to 81. In the embodiment of FIGS.
2 to 13, the mitral valve replacement implant 200 had the
trampoline lattice 230 projecting through the implant skirt 240 on
the ventricle side of the implant 200. The exemplary embodiment of
the mitral valve replacement implant 600 in FIGS. 78 to 81 provides
the trampoline lattice 630 with the inner circumferential valve
portion 634 on the opposing side and projecting out from the side
of the implant 600 with the wall-retaining petals 648. The
expandable outer trampoline portion 632 is visible in FIG. 76. The
framework of the implant 600 is shown without the external
coverings and valve material in FIGS. 77, 79, and 81 to expose the
adjustable stent lattice 610, the skirt lattice 642, and the
wall-retaining petals 648.
A second alternative configuration of a circular valve replacement
implant 600 is shown in FIGS. 82 to 87. In the embodiment of FIGS.
78 to 81, the implant 600 had an overall D-shape and the
wall-retaining petals 648 were uncovered. The exemplary embodiment
of the valve replacement implant 700 in FIGS. 82 to 87 likewise
provides the trampoline lattice 730 with the inner circumferential
valve portion 734 on the side opposite the implant skirt 740
projecting out from the side of the implant 700 with the
wall-retaining petals 748 but is circular in its overall shape.
Both the expandable outer trampoline portion 732 and the inner
circumferential valve portion 734 are visible in FIG. 82. As can be
seen, the material 744 of the implant skirt 740 also covers the
wall-retaining petals 748. The framework of the implant 700 is
shown without the external coverings and valve material in FIGS.
83, 85, and 87 to expose the adjustable stent lattice 710, the
skirt lattice 742, and the wall-retaining petals 748. Because the
disconnect lumens 140 and the drive wires 150 connect from the side
of the wall-retaining petals 748, the nosecone 120 is on the side
of the implant skirt 740.
A third alternative configuration of a circular valve replacement
implant 800 is shown in FIGS. 88 to 93. In the embodiment of FIGS.
82 to 87, the implant 700 had an overall circular shape and the
wall-retaining petals 748 were covered. Like the implant 700, the
implant 800 is circular in its overall shape. In contrast to the
implant 700, however, the exemplary embodiment of the valve
replacement implant 800 in FIGS. 88 to 93 has the trampoline
lattice 830 with the inner circumferential valve portion 834 on the
side opposite the wall-retaining petals 848 to project out from the
side of the implant 800 having the implant skirt 840. The
expandable outer trampoline portion 832 is visible from the
interior of the implant 800 in FIG. 88 and the inner
circumferential valve portion 834 is visible in both FIGS. 90 and
92. As can be seen, the material 844 of the implant skirt 840 does
not cover the wall-retaining petals 848, but it does project into
the central orifices defined by each petal 848 in order to cover
the proximal jack strut 812. The framework of the implant 800 is
shown without the external coverings and valve material in FIGS.
89, 91, and 93 to expose the adjustable stent lattice 810, the
skirt lattice 842, and the wall-retaining petals 848. Because the
disconnect lumens 140 and the drive wires 150 connect from the side
of the wall-retaining petals 848, the nosecone 120 is on the side
of the implant skirt 840.
A fourth alternative configuration of a circular valve replacement
implant 900 is shown in FIGS. 94 and 95. In contrast to the
previous exemplary embodiments, the implant 900 has no exterior
skirt, has no wall-retaining petals, and does not have the
trampoline valve. The implant 900 has an overall circular shape and
a tricuspid valve with leaflets 952 attached to the interior of the
adjustable stent lattice 910.
A fifth alternative configuration of a circular valve replacement
implant 1000 is shown in FIGS. 96 to 99. In contrast to the
previous exemplary embodiments, the implant 1000 has a
self-expanding valve trampoline lattice 1030 but it does not have
an exterior skirt or wall-retaining petals. The trampoline lattice
1030 has an inner circumferential valve portion 1034 on a side
where the disconnect lumens 140 project out from the proximal end
of the adjustable stent lattice 1010. The expandable outer
trampoline portion 1032 is visible from the interior of the implant
1000 in FIG. 96 and the inner circumferential valve portion 1034 is
visible in both FIGS. 96 and 97 with the internal leaflets 1052 is
visible in FIG. 97. The framework of the implant 1000 is shown
without the external coverings and valve material in FIGS. 98 and
99 to expose the adjustable stent lattice 1010 and the trampoline
lattice 1030. Because the disconnect lumens 140 and the drive wires
150 connect from the side of the inner circumferential valve
portion 1034, the nosecone 120 is on the side opposite the inner
circumferential valve portion 1034.
A sixth alternative configuration of a circular valve replacement
implant 1100 is shown in FIGS. 100 to 102. In contrast to the
previous exemplary embodiments, the implant 1100 has an exterior
implant skirt 1140 but it does not have self-expanding valve
trampoline lattice or wall-retaining petals. The valve contained
within the adjustable stent lattice 1110 has three leaflets 1152,
which are shown in FIGS. 100 and 101. The implant 1100 is installed
from the side of the adjustable stent lattice 1110 having the
implant skirt 1140, the side where the disconnect lumens 140
project out from the proximal end of the adjustable stent lattice
1110. Because the disconnect lumens 140 and the drive wires 150
connect from the side of the implant skirt 1140, the nosecone 120
is on the side opposite the implant skirt 1140, as shown in FIG.
101.
The framework of the implant 1100 is shown without the external
coverings and valve material in FIG. 102 to expose the adjustable
stent lattice 1110 and the lattice of the skirt 1140, as well as
their various components. The implant skirt 1140, in this exemplary
embodiment comprises only one part, an outer circumferential ring.
This implant skirt 1140 does not connect to the adjustable stent
lattice with intervening struts as in some of the above
embodiments. The skirt 1140 is made of a material that is
self-expanding and has a desired, pre-set shape (such as heat-set
nitinol, for example). The adjustable stent lattice 1110 comprises
sets of jack screw connectors, each set having a proximal jack
strut 1112 and a distal jack strut 1114. Arms 1116 connect each of
the proximal and distal jack struts 1112, 1114 to an intermediate
strut 1118. Jack screws 1120 connect to the proximal and distal
jack struts 1112, 1114 so that, when the jack screw 1120 is turned
in one direction, the proximal and distal jack struts 1112, 114
separate from one another and, when the jack screw 1120 is turned
in the other opposite direction, the proximal and distal jack
struts 1112, 1114 move towards one another. This configuration can
be achieved in various ways as described above and, therefore, this
is not repeated here.
With such a configuration, rotation of the many jack screws 1120 in
the strut-approaching direction causes the proximal and distal jack
struts 1112, 1114 to move towards one another and, thereby, push
the intermediate struts 1118 (which are disposed parallel to the
jack screws 1120) away from the jack screw 1120 in a direction
along the circumferential extent of the annulus of the adjustable
stent lattice 1110. This relative movement of the intermediate
strut 1118 and the jack screw assemblies causes expansion of the
adjustable stent lattice 1110 when the proximal and distal jack
struts 1112, 1114 move towards one another and causes contraction
of the adjustable stent lattice 1110 when the proximal and distal
jack struts 1112, 1114 move away from one another. Ideally, all of
the jack screws 120 are rotated at the same speed to but such equal
movement is not to be considered limiting.
In the exemplary embodiment of the adjustable stent lattice 1110
shown, there are eight pairs of jack struts 1112, 1114 and eight
intermediate struts 1118. This number is merely exemplary and there
can be, for example, only six of each or any other number desired
including any number from 1 to 10. Connecting the pairs of jack
struts 1112, 1114 and the intermediate struts 1118 are the
laterally extending arms 1116, which, in this exemplary embodiment
is two for each of the proximal and distal jack struts 1112, 1114,
but this number is not limiting. As the adjustable stent lattice
1110 is either contracted or expanded, the arms 1116 each flex at
their two endpoints, one at a respective intermediate strut 1118
and the other at a respective one of a pair of jack struts 1112,
1114. When the adjustable stent lattice 1110 is contracted (e.g.,
for installation into the delivery sheath 130), the arms 1116 move
towards a longitudinal orientation (parallel to the jack screws and
to the central axis of the lattice 1110. Conversely, when the
adjustable stent lattice 1110 is expanded (e.g., for implantation),
the arms 1116 angle away from the respective intermediate strut
1118 and one of the pair of jack struts 1112, 1114 in a
circumferential orientation (perpendicular to the jack screws).
A seventh alternative configuration of a circular valve replacement
implant 1200 is shown in FIGS. 103 and 104. In contrast to the
previous exemplary embodiments, the implant 1200 has an exterior
implant skirt 1240 and a self-expanding valve trampoline lattice
1230 but it does not have wall-retaining petals. The trampoline
lattice 1230 has an inner circumferential valve portion 1234 on the
side of the implant skirt 1240 where the disconnect lumens 140
project out from the proximal end of the adjustable stent lattice
1210. The expandable outer trampoline portion 1232 is visible from
the interior of the implant 1200 in FIG. 103 and the inner
circumferential valve portion 1234 is visible in FIG. 104 with the
internal leaflets 1252 also visible there, three in number in this
example. The implant 1200 is installed from the skirt side of the
adjustable stent lattice 1210 where the inner circumferential valve
portion 1234 exists and the side where the disconnect lumens 140
project out from the proximal end of the adjustable stent lattice
1210. Because the disconnect lumens 140 and the drive wires 150
connect from the side of the inner circumferential valve portion
1234, the nosecone 120 is on the side opposite the inner
circumferential valve portion 1234.
In the above embodiments, memory shape and other metallic lattices
were described. These lattices can have a material thickness of
between 0.6 mm (0.024'') and 0.9 mm (0.035'') and any number
therebetween, in particular between 0.7 mm (0.028'') and 0.8 mm
(0.032'') and any number therebetween.
With mitral valve replacement implants having a trampoline valve,
the number of sizes needed to cover the range of patient population
is decreased from prior art TAVR replacement valves, which
generally requires at least four sizes to be available for use. For
the trampoline valves described herein, a 22 mm diameter valve can
reside within a valve trampoline lattice having an expanded
diameter starting at approximately 25 mm at its smallest to
approximately 40 mm at its largest size. A 30 mm diameter valve can
reside within a valve trampoline lattice having an expanded
diameter starting at approximately 40 mm at its smallest to
approximately 55 mm at its largest size. With a valve diameter
range of between 25 mm and 55 mm, this means that the
herein-described mitral valve implants having valve trampolines can
cover the entire range of expected patient population with only two
sizes.
The catheter sheaths required to implant these two are
approximately 28 Fr to 32 Fr for the 25 mm to 40 mm size and 32 Fr
to 35 Fr for the 40 mm to 55 mm size. Well within the desired range
of catheters for such valve replacement procedures. It is further
noted that if porcine pericardium is used for the valve leaflets,
the size of the delivery sheath can be reduced, in particular, to
25 Fr to 29 Fr and 29 to 32 Fr, respectively.
It is noted that various individual features of the inventive
processes and systems may be described only in one exemplary
embodiment herein. The particular choice for description herein
with regard to a single exemplary embodiment is not to be taken as
a limitation that the particular feature is only applicable to the
embodiment in which it is described. All features described herein
are equally applicable to, additive, or interchangeable with any or
all of the other exemplary embodiments described herein and in any
combination or grouping or arrangement. In particular, use of a
single reference numeral herein to illustrate, define, or describe
a particular feature does not mean that the feature cannot be
associated or equated to another feature in another drawing figure
or description. Further, where two or more reference numerals are
used in the figures or in the drawings, this should not be
construed as being limited to only those embodiments or features,
they are equally applicable to similar features or not a reference
numeral is used or another reference numeral is omitted.
The foregoing description and accompanying drawings illustrate the
principles, exemplary embodiments, and modes of operation of the
systems, apparatuses, and methods. However, the systems,
apparatuses, and methods should not be construed as being limited
to the particular embodiments discussed above. Additional
variations of the embodiments discussed above will be appreciated
by those skilled in the art and the above-described embodiments
should be regarded as illustrative rather than restrictive.
Accordingly, it should be appreciated that variations to those
embodiments can be made by those skilled in the art without
departing from the scope of the systems, apparatuses, and methods
as defined by the following claims.
* * * * *
References